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Prescription medicines: registration of new generic medicines and biosimilar medicines

16 September 2019

Throughout the year, we will be publishing information on new generic and biosimilar prescription medicines as they are approved. Please note that the sponsor name reflects the information in the Australian Register of Therapeutic Goods (ARTG) at the time of registration. As sponsors may change over time, consult the ARTG for full information in relation to these products, including full indications.

Once an application has been accepted for evaluation by TGA, the approval time is defined as the number of TGA working days between commencement of evaluation and registration decision. TGA works to business target timeframes as well as to legislated timeframes for each category of application. Approval times are underpinned by legislation (see Therapeutic Goods Regulations 1990) and excludes public holidays, weekends, the time allocated to the sponsor to respond to requests for information, 'mutual clock stop' periods agreed with the sponsor, or other review activities.

Approval times are reported in the number of TGA working days for each new registration, along with the legislated timeframe (unless otherwise indicated) for that category of application in brackets.

Generic medicines

A generic medicine is an additional brand of an existing medicine. It contains the same 'active ingredient' as the existing medicine; the 'active ingredient' is the chemical that is biologically active in the body and makes the medicine work. Active ingredients can be manufactured and sold by other sponsors once the patent for the existing brand medicine has expired.

Apart from containing the same active ingredient, generic medicines must also be 'bioequivalent'. This means that the same amount of active ingredient is absorbed by the body over the same period of time for the same dose of generic or existing medicine.

A 'first generic' medicine is the first registration approved by TGA which permits a sponsor to market a generic drug product in Australia that contains a particular active ingredient. First generics are significant because they have the potential to create more affordable treatment options for patients by triggering a price reduction under the Pharmaceutical Benefits Scheme (PBS). Because the first generic registered by TGA may not necessarily be the first that is PBS listed, please consult the PBS website for further information.

Biosimilar medicines

A biosimilar medicine is a version of a biological medicine that is already registered and is referred to as the 'reference medicine'.

Both the biosimilar medicine and its reference medicine will have similar core characteristics such as physicochemical, biological, immunological, efficacy and safety, which are demonstrated using comprehensive comparability studies. Most biosimilar medicines are likely to contain biotechnology-derived proteins as the active substance.


symbol denoting a first generic

First generic: first TGA approval of a new medicine that contains the same active ingredient as an existing medicine and is bioequivalent to that medicine


Registration of new generic medicines and biosimilar medicines, 2019

Previous years

2018 2017

August 2019

TRAZIMERA

Evaluation commenced: 1 Aug 2018

Registration decision: 19 Jul 2019

Date registered: 19 Aug 2019

Approval time: 196 working days (255)

trastuzumab

Pfizer Australia Pty Ltd

New biosimilar medicine

Early Breast Cancer

TRAZIMERA (powder for injection) is indicated for the treatment of HER2-positive early breast cancer following surgery, and in association with chemotherapy and, if applicable, radiotherapy.

Locally Advanced Breast Cancer

TRAZIMERA is indicated for the treatment of HER2-positive locally advanced breast cancer in combination with neoadjuvant chemotherapy followed by adjuvant TRAZIMERA.

Metastatic Breast Cancer

TRAZIMERA is indicated for the treatment of patients with metastatic breast cancer who have tumours that overexpress HER2:

  • as monotherapy for the treatment of those patients who have received one or more chemotherapy regimens for their metastatic disease;
  • in combination with taxanes for the treatment of those patients who have not received chemotherapy for their metastatic disease; or
  • in combination with an aromatase inhibitor for the treatment of post-menopausal patients with hormone-receptor positive metastatic breast cancer.
Advanced Gastric Cancer

TRAZIMERA is indicated in combination with cisplatin and either capecitabine or 5-FU for the treatment of patients with HER2 positive advanced adenocarcinoma of the stomach or gastro-oesophageal junction who have not received prior anti-cancer treatment for their metastatic disease.

LAPELGA, NEUTROPEG

Evaluation commenced: 31 Aug 2018

Registration decision: 24 Jul 2019

Date registered: 19 Aug 2019

Approval time: 183 working days (255)

pegfilgrastim

Apotex Pty Ltd

New biosimilar medicine

LAPELGA, NEUTROPEG (solution for injection) are indicated for the treatment of cancer patients following chemotherapy, to decrease the duration of severe neutropenia and so reduce the incidence of infection, as manifested by febrile neutropenia.

AMIKACIN EMC

Evaluation commenced: 28 Sep 2018

Registration decision: 25 Jul 2019

Date registered: 13 Aug 2019

Approval time: 162 working days (255)

amikacin (as sulfate)

Emcure Pharmaceuticals Pty Ltd

New generic medicine

AMIKACIN EMC (solution for injection) is indicated in the short-term treatment of serious infections caused by susceptible strains of Gram-negative bacteria.

Staphylococcus aureus, including methicillin-resistant strains is the principal Gram-positive organism sensitive to amikacin.

The use of amikacin in the treatment of staphylococcal infections should be restricted to second-line therapy, and should be confined to patients suffering from severe infections caused by susceptible strains of stapylococcus who have failed to respond or are allergic to other available antibiotics.

AMIKACIN EMC is indicated in the treatment of neonatal sepsis when sensitivity testing indicates that other aminoglycosides cannot be used.

In certain severe infections such as neonatal sepsis, concomitant therapy with a penicillin type drug may be indicated because of the possibility of infections due to Gram-positive organisms such as streptococci or pneumococci. If concomitant treatment with a penicillin type drug is indicated, then the drugs should be administered separately because in-vitro mixing of the two drugs causes inactivation of amikacin.

Clinical studies have shown amikacin to be effective in treating bacteraemia, septicaemia including neonatal sepsis and serious infections of the respiratory tract, bones and joints, central nervous system, skin and skin structures (including those resulting from burns), intra-abdominal organs, post-operative infections and complicated and recurrent urinary tract infections, when caused by susceptible organisms.

MOXIFLOXACIN APO

Evaluation commenced: 31 Oct 2018

Registration decision: 31 Jul 2019

Date registered: 9 Aug 2019

Approval time: 143 working days (255)

moxifloxacin (as hydrochloride)

Accelagen Pty Ltd

New generic medicine

MOXIFLOXACIN APO (tablets) are indicated for the treatment of adults with infections caused by susceptible organisms in the conditions:

  • Acute bacterial sinusitis
  • Community acquired pneumonia
  • Acute exacerbations of chronic bronchitis

Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing infection and to determine their susceptibility to moxifloxacin. Therapy with MOXIFLOXACIN APO may be initiated, in some conditions, before results of these tests are known. Once results become available, therapy should be continued with the most appropriate antibiotic therapy.

Consideration should be given to available official guidance on the appropriate use of antibacterial agents.

BUSULFAN ACCORD, BUSULFAN INTAS

Evaluation commenced: 31 May 2018

Registration decision: 31 Jul 2019

Date registered: 2 Aug 2019

Approval time: 249 working days (255)

busulfan

Accord Healthcare Pty Ltd

New generic medicine

BUSULFAN ACCORD, BUSULFAN INTAS (solution for injection) are indicated for use in combination with cyclophosphamide, melphalan or fludarabine in conditioning prior to haematopoietic stem cell transplantation.

July 2019

AZACITIDINE-TEVA

Evaluation commenced: 28 Feb 2018

Registration decision: 5 Jul 2019

Date registered: 23 Jul 2019

Approval time: 252 working days (255)

azacitidine

Teva Pharma Australia Pty Ltd

New generic medicine

AZACITIDINE-TEVA (powder for injection) is indicated for the treatment of patients with:

  • Intermediate-2 and high-risk Myelodysplastic Syndromes (MDS) according to the International Prognostic Scoring System (IPSS),
  • Chronic Myelomonocytic Leukemia [CMMoL (10%-29% marrow blasts without Myeloproliferative Disorder)],
  • Acute Myeloid Leukemia (AML) with 20-30% blasts and multi-lineage dysplasia, according to World Health Organisation Classification (WHO),

in whom allogenic stem cell transplantation is not indicated.

PREGABALIN ARW, PREGABALIN CW, PREGABALIN TIH

Evaluation commenced: 30 Aug 2018

Registration decision: 14 Jun 2019

Date registered: 23 Jul 2019

Approval time: 153 working days (255)

pregabalin

Arrow Pharma Pty Ltd

New generic medicine

PREGABALIN ARW, PREGABALIN CW, PREGABALIN TIH (capsules) are indicated for the treatment of neuropathic pain in adults.

PREGABALIN ARW, PREGABALIN CW, PREGABALIN TIH are indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.

ERTAPENEM JUNO

Evaluation commenced: 31 Jul 2017

Registration decision: 29 Jun 2018

Date registered: 17 Jul 2019

Approval time: 161 working days (255)

ertapenem

Juno Pharmaceuticals Pty Ltd

New generic medicine

ERTAPENEM JUNO (powder for injection) is indicated for the treatment of patients, aged 3 months or more, with moderate to severe infections (except meningitis, see PRECAUTIONS) caused by susceptible strains of microorganisms which are suspected or proven to be resistant to all other antibiotics, or for patients unable to tolerate other antibiotics.

ERTAPENEM JUNO is also indicated for initial empiric therapy for the treatment of complicated intra-abdominal infections and acute pelvic infections including post-partum endomyometritis, septic abortion and post-surgical gynaecological infections.

ERTAPENEM JUNO is also indicated for the treatment of diabetic foot infections, which require parenteral antibiotic therapy and are caused by susceptible bacterial pathogens which are suspected or proven to be resistant to all other registered antibiotics, or for patients unable to tolerate other antibiotics.

Appropriate specimens for bacteriological examination should be obtained in order to isolate and identify the causative organisms and to determine their susceptibility to ertapenem. Therapy with ERTAPENEM JUNO may be initiated empirically before the results of these tests are known; once these results become available, antimicrobial therapy, should be adjusted accordingly.

VORICONAZOLE KABI

Evaluation commenced: 2 Jul 2018

Registration decision: 8 Jul 2019

Date registered: 12 Jul 2019

Approval time: 153 working days (255)

voriconazole

Fresenius Kabi Australia Pty Ltd

New generic medicine

VORICONAZOLE KABI (powder for injection) is indicated for treatment of the following fungal infections:

  • Invasive aspergillosis.
  • Serious Candida infections (including C. krusei), including systemic Candida infections (hepatosplenic candidiasis, disseminated candidiasis, candidaemia).
  • Serious fungal infections caused by Scedosporium spp. and Fusarium spp.
  • Other serious fungal infections, in patients intolerant of, or refractory to, other therapy.

Prophylaxis in patients who are at high risk of developing invasive fungal infections. The indication is based on studies including patients undergoing haematopoietic stem cell transplantation.

MEDICIANZ MORPHINE SULFATE, MEDSURGE MORPHINE SULFATE

Evaluation commenced: 28 Sep 2018

Registration decision: 2 Jul 2019

Date registered: 9 Jul 2019

Approval time: 143 working days (255)

morphine sulfate pentahydrate

Medicianz Healthcare Pty Ltd

New generic medicine

MEDICIANZ MORPHINE SULFATE, MEDSURGE MORPHINE SULFATE (solution for injection) are indicated for the relief of moderate to severe pain not responsive to non-opioid analgesics. It may also be used as a pre-operative medication and as an analgesic adjunct in general anaesthesia.

ONDANSETRON-AFT

Evaluation commenced: 30 Apr 2018

Registration decision: 28 Jun 2019

Date registered: 4 Jul 2019

Approval time: 249 working days (255)

ondansetron

AFT Pharmaceuticals Pty Ltd

New generic medicine

ONDANSETRON-AFT (solution for injection) is indicated for the prevention and treatment of nausea and vomiting induced by cytotoxic therapy and radiotherapy. ONDANSETRON-AFT is also indicated for the prevention and treatment of post-operative nausea and vomiting.

APREPITANT RMB, APREPITANT SCP

Evaluation commenced: 31 Oct 2018

Registration decision: 21 Jun 2019

Date registered: 3 Jul 2019

Approval time: 117 working days (255)

aprepitant

Southern Cross Pharma Pty Ltd

New generic medicine

APREPITANT RMB, APREPITANT SCP (capsules) in combination with other antiemetic agents, are indicated for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of:

  • highly emetogenic cancer chemotherapy.
  • moderately emetogenic cancer chemotherapy.

APREPITANT RMB, APREPITANT SCP are indicated for the prevention of postoperative nausea and vomiting.

MOXODENE, MOXONIDINE GPPL, MOXONIDINE GENPAR, MOXOTENS

Evaluation commenced: 30 Apr 2018

Registration decision: 21 Jun 2019

Date registered: 2 Jul 2019

Approval time: 244 working days (255)

moxonidine

Generic Partners Pty Ltd

New generic medicine

MOXODENE, MOXONIDINE GPPL, MOXONIDINE GENPAR, MOXOTENS (tablets) are indicated for the treatment of hypertension.

June 2019

CARBETOCIN WOCKHARDT, CARBETOCIN WKT first generic

Evaluation commenced: 31 Aug 2018

Registration decision: 30 May 2019

Date registered: 27 Jun 2019

Approval time: 160 working days (255)

carbetocin

Wockhardt Bio Pty Ltd

New generic medicine

CARBETOCIN WOCKHARDT, CARBETOCIN WKT (solution for IV injection) are indicated for the prevention of uterine atony and excessive bleeding following delivery of the infant by caesarean section or vaginal delivery.

CARBETOCIN WOCKHARDT, CARBETOCIN WKT must be administered after delivery of the infant.

DEXMEDETOMIDINE INTAS, DEXMEDETOMIDINE ACCORD

Evaluation commenced: 30 Aug 2018

Registration decision: 11 Jun 2019

Date registered: 18 Jun 2019

Approval time: 151 working days (255)

dexmedetomidine

Accord Healthcare Pty Ltd

New generic medicine

ICU Sedation

DEXMEDETOMIDINE INTAS, DEXMEDETOMIDINE ACCORD (solution for injection) are indicated for sedation of initially intubated patients during treatment in an intensive care setting. The use of DEXMEDETOMIDINE INTAS, DEXMEDETOMIDINE ACCORD by continuous infusion in these patients should not exceed 24 hours.

Procedural Sedation

DEXMEDETOMIDINE INTAS, DEXMEDETOMIDINE ACCORD are indicated for sedation of non-intubated patients prior to and/or during surgical and other procedures.

MERCAPTOPURINE-LINK

Evaluation commenced: 1 Aug 2018

Registration decision: 11 Jun 2019

Date registered: 14 Jun 2019

Approval time: 152 working days (255)

mercaptopurine monohydrate

Link Medical Products Pty Ltd

New generic medicine

MERCAPTOPURINE-LINK (tablets) is indicated for the treatment of acute leukaemia. It is of value in remission induction and is particularly indicated for maintenance therapy in acute lymphoblastic leukaemia and acute myelogenous leukaemia. MERCAPTOPURINE-LINK is also used in the treatment of chronic granulocytic leukaemia.

APO-TRAVOPROST/TIMOLOL first generic

Evaluation commenced: 2 Jul 2018

Registration decision: 5 Jun 2019

Date registered: 12 Jun 2019

Approval time: 171 working days (255)

travoprost/timolol

Apotex Pty Ltd

New generic medicine

APO-TRAVOPROST/TIMOLOL (eye drops) are indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension for whom single agent therapy provides insufficient intraocular pressure reduction.

XILENTO, TACETAN, TACCASART, XILECAND, DESACAND, CANDESARTAN GPPL, CANDESARTAN BUR, DESARTACAN

Evaluation commenced: 28 Feb 2018

Registration decision: 16 May 2019

Date registered: 11 Jun 2019

Approval time: 252 working days (255)

candesartan cilexetil

Generic Partners Pty Ltd

New generic medicine

XILENTO, TACETAN, TACCASART, XILECAND, DESACAND, CANDESARTAN GPPL, CANDESARTAN BUR, DESARTACAN (tablets) are indicated for the treatment of hypertension.

XILENTO, TACETAN, TACCASART, XILECAND, DESACAND, CANDESARTAN GPPL, CANDESARTAN BUR, DESARTACAN are indicated for the treatment of patients with heart failure and impaired left ventricular systolic function (left ventricular ejection fraction less than or equal to 40 percent) as add-on therapy to ACE inhibitors or when ACE inhibitors are not tolerated.

DESACAND HCT, DESARTACAN HCT, CANDESARTAN HCTZ GPPL, TACCASART HCT, CANDESARTAN BUR HCT, TACETAN HCT, XILECAND HCT, XILENTO HCT

Evaluation commenced: 28 Feb 2018

Registration decision: 16 May 2019

Date registered: 11 Jun 2019

Approval time: 251 working days (255)

candesartan cilexetil and hydrochlorothiazide

Generic Partners Pty Ltd

New generic medicine

DESACAND HCT, DESARTACAN HCT, CANDESARTAN HCTZ GPPL, TACCASART HCT, CANDESARTAN BUR HCT, TACETAN HCT, XILECAND HCT, XILENTO HCT (tablets) are indicated for the treatment of hypertension. Treatment should not be initiated with these fixed dose combinations.

APREPITANT APOTEX first generic

Evaluation commenced: 28 Sep 2018

Registration decision: 30 May 2019

Date registered: 11 Jun 2019

Approval time: 122 working days (255)

aprepitant

Apotex Pty Ltd

New generic medicine

APREPITANT APOTEX (capsules), in combination with other antiemetic agents, is indicated for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of:

  • highly emetogenic cancer chemotherapy.
  • moderately emetogenic cancer chemotherapy.

APREPITANT APOTEX is indicated for the prevention of postoperative nausea and vomiting.

May 2019

SOLIFENACIN AMEDA, VESICAN, SOLIFENACIN GENERICHEALTH, SEFICARE, SOLIFENACIN INTAS

Evaluation commenced: 2 Jan 2018

Registration decision: 20 May 2019

Date registered: 29 May 2019

Approval time: 212 working days (255)

solifenacin succinate

Accord Healthcare Pty Ltd

New generic medicine

SOLIFENACIN AMEDA, VESICAN, SOLIFENACIN GENERICHEALTH, SEFICARE, SOLIFENACIN INTAS (film-coated tablets) are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency or increased urinary frequency.

LACOSAMIDE ASTRON, LACOSIMPAT, LACOSAMIDE AMEDA, LACOSAMIDE INTAS, LACOSAM

Evaluation commenced: 21 Dec 2017

Registration decision: 21 Nov 2018

Date registered: 29 May 2019

Approval time: 190 working days (255)

lacosamide

Accord Healthcare Pty Ltd

New generic medicine

LACOSAMIDE ASTRON, LACOSIMPAT, LACOSAMIDE AMEDA, LACOSAMIDE INTAS, LACOSAM (film-coated tablets) are indicated as:

  • monotherapy in the treatment of partial seizures with or without secondary generalisation in patients with epilepsy aged 16 years and older.
  • add-on therapy in the treatment of partial seizures with or without secondary generalisation in patients with epilepsy aged 4 years and older.

GXP OXYCODONE, OXYCODONE JL, OXYCODONE NH, OXYCODONE NHPL, OXYCODOR LIQUID, OXYCODOR, OXYLENUS, OXYCODONE CP, OXYCODONE AB, OXYCODONE GPPL, OXYCODONE MLP, GXP OXYCODONE LIQUID, OXYNDONE, OXYLENUS LIQUID , OXYCODONE GENPAR, OXYCODONE GPPL LIQUID, OXYCODONE NEO HEALTH

Evaluation commenced: 2 Feb 2018

Registration decision: 21 May 2019

Date registered: 29 May 2019

Approval time: 200 working days (255)

oxycodone hydrochloride

Neo Health (Australia) Pty Ltd

New generic medicine

OXYCODONE GENPAR, OXYCODONE NEO HEALTH, OXYCODONE NHPL, OXYNDONE are indicated for the management of opioid-responsive, moderate to severe pain.

GXP OXYCODONE, GXP OXYCODONE LIQUID, OXYCODONE GPPL, OXYCODONE GPPL LIQUID, OXYLENUS, OXYLENUS LIQUID, OXYCODONE JL, OXYCODOR, OXYCODOR LIQUID, OXYCODONE NH, OXYCODONE MLP, OXYCODONE CP, OXYCODONE AB are indicated for the management of opioid-responsive moderate to severe pain.

TERIFLUNOMIDE INTAS, TERIFLAGIO, TERINTAS

Evaluation commenced: 31 Jul 2018

Registration decision: 20 May 2019

Date registered: 24 May 2019

Approval time: 141 working days (255)

teriflunomide

Accord Healthcare Pty Ltd

New generic medicine

TERIFLUNOMIDE INTAS, TERIFLAGIO, TERINTAS (film-coated tablets) are indicated for the treatment of patients with relapsing forms of Multiple Sclerosis to reduce the frequency of clinical relapses and to delay the progression of physical disability.

ELETRIPTAN GPPL, ELTRIPAX, ELPAXTAN, ELYSS, ELETRIPTAN GENPAR, ELETRIPTAN GXP, ELETX first generic

Evaluation commenced: 31 Jan 2018

Registration decision: 17 May 2019

Date registered: 21 May 2019

Approval time: 186 working days (255)

eletriptan

Generic Partners Pty Ltd

New generic medicine

ELETRIPTAN GPPL, ELTRIPAX, ELPAXTAN, ELYSS, ELETRIPTAN GENPAR, ELETRIPTAN GXP, ELETX (film-coated tablets) are indicated for acute treatment of migraine headache with or without aura.

BUPIVACAINE SPINAL HEAVY BNM

Evaluation commenced: 21 Dec 2017

Registration decision: 20 Nov 2018

Date registered: 20 May 2019

Approval time: 183 working days (255)

bupivacaine hydrochloride

Boucher & Muir Pty Ltd

New generic medicine

BUPIVACAINE SPINAL HEAVY BNM (solution for injection) is indicated for the production of spinal anaesthesia.

BUPIVACAINE SPINAL HEAVY BNM is suitable for abdominal surgery lasting 45 - 60 minutes and urological and lower limb surgery lasting 2 - 3 hours.

APO-FENOFIBRATE, FENOFIBRATE AJS, BLOOMS THE CHEMIST FENOFIBRATE, FENOFIBRATE APOTEX, FENOFIBRATE SCP

Evaluation commenced: 1 Aug 2017

Registration decision: 29 Apr 2019

Date registered: 17 May 2019

Approval time: 246 working days (255)

fenofibrate

Southern Cross Pharma Pty Ltd

New generic medicine

APO-FENOFIBRATE, FENOFIBRATE AJS, BLOOMS THE CHEMIST FENOFIBRATE, FENOFIBRATE APOTEX, FENOFIBRATE SCP (tablets) are indicated as an adjunct to diet in the treatment of:

  • hypercholesterolaemia;
  • types II, III, IV and V dyslipidaemia;
  • dyslipidaemia associated with type 2 diabetes

APO-FENOFIBRATE, FENOFIBRATE AJS, BLOOMS THE CHEMIST FENOFIBRATE, FENOFIBRATE APOTEX, FENOFIBRATE SCP is indicated for the reduction in the progression of diabetic retinopathy in patients with type 2 diabetes and existing diabetic retinopathy. Fenofibrate does not replace the appropriate control of blood pressure, blood glucose and blood lipids in reducing the progression of diabetic retinopathy.

VALLITTE, VALGANE, VALGANCICLOVIR GXP, VALGANCICLOVIR GENPAR, VALGANCICLOVIR GPPL, CLOVIGAN

Evaluation commenced: 31 May 2018

Registration decision: 13 May 2019

Date registered: 16 May 2019

Approval time: 175 working days (255)

valganciclovir

Generic Partners Pty Ltd

New generic medicine

VALLITTE, VALGANE, VALGANCICLOVIR GXP, VALGANCICLOVIR GENPAR, VALGANCICLOVIR GPPL, CLOVIGAN (film-coated tablets) are indicated for the treatment of cytomegalovirus (CMV) retinitis in adult patients with acquired immunodeficiency syndrome (AIDS).

VALLITTE, VALGANE, VALGANCICLOVIR GXP, VALGANCICLOVIR GENPAR, VALGANCICLOVIR GPPL, CLOVIGAN is indicated for the prophylaxis of CMV disease in adult and paediatric solid organ transplantation (SOT) patients who are at risk.

KANJINTI

Evaluation commenced: 22 Dec 2017

Registration decision: 8 Jan 2019

Date registered: 16 May 2019

Approval time: 186 working days (255)

trastuzumab

Amgen Australia Pty Ltd

New biosimilar medicine

Early Breast Cancer

KANJINTI (powder for injection) is indicated for the treatment of HER2-positive early breast cancer following surgery, and in association with chemotherapy and, if applicable, radiotherapy.

Locally Advanced Breast Cancer

KANJINTI is indicated for the treatment of HER2-positive locally advanced breast cancer in combination with neoadjuvant chemotherapy followed by adjuvant KANJINTI.

Metastatic Breast Cancer

KANJINTI is indicated for the treatment of patients with metastatic breast cancer who have tumours that overexpress HER2:

  • as monotherapy for the treatment of those patients who have received one or more chemotherapy regimens for their metastatic disease;
  • in combination with taxanes for the treatment of those patients who have not received chemotherapy for their metastatic disease; or
  • in combination with an aromatase inhibitor for the treatment of post-menopausal patients with hormone-receptor positive metastatic breast cancer.
Advanced Gastric Cancer

KANJINTI is indicated in combination with cisplatin and either capecitabine or 5-FU for the treatment of patients with HER2 positive advanced adenocarcinoma of the stomach or gastro-oesophageal junction who have not received prior anti-cancer treatment for their metastatic disease.

BORTEZOMIB-TEVA

Evaluation commenced: 29 Sep 2017

Registration decision: 13 Feb 2019

Date registered: 14 May 2019

Approval time: 250 working days (255)

bortezomib

Teva Pharma Australia Pty Ltd

New generic medicine

BORTEZOMIB-TEVA (powder for injection), in combination with melphalan and prednisone is indicated for the treatment of patients with previously untreated multiple myeloma who are not candidates for high dose chemotherapy.

BORTEZOMIB-TEVA, as part of combination therapy, is indicated for induction therapy prior to high dose chemotherapy with autologous stem cell rescue for patients under 65 years of age with previously untreated multiple myeloma.

BORTEZOMIB-TEVA is also indicated for the treatment of multiple myeloma patients who have received at least one prior therapy, and who have progressive disease.

BORTEZOMIB-TEVA in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma.

MSN-BORTEZOMIB

Evaluation commenced: 31 Jul 2018

Registration decision: 9 May 2019

Date registered: 14 May 2019

Approval time: 152 working days (255)

bortezomib

Plunkett Consulting Pty Ltd

New generic medicine

MSN-BORTEZOMIB (powder for injection), in combination with melphalan and prednisone is indicated for the treatment of patients with previously untreated multiple myeloma who are not candidates for high dose chemotherapy.

MSN-BORTEZOMIB as part of combination therapy, is indicated for induction therapy prior to high dose chemotherapy with autologous stem cell rescue for patients under 65 years of age with previously untreated multiple myeloma.

MSN-BORTEZOMIB is also indicated for the treatment of multiple myeloma patients who have received at least one prior therapy, and who have progressive disease.

MSN-BORTEZOMIB in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma.

AZITHROMYCIN-AFT

Evaluation commenced: 28 Feb 2018

Registration decision: 6 May 2019

Date registered: 10 May 2019

Approval time: 251 working days (255)

azithromycin

AFT Pharmaceuticals Pty Ltd

New generic medicine

AZITHROMYCIN-AFT (powder for injection) is indicated for the treatment of community acquired pneumonia caused by susceptible organisms in patients who require initial intravenous therapy. In clinical studies efficacy has been demonstrated against Chlamydia pneumoniae, Haemophilus influenzae, Legionella pneumophilia, Moraxella catarrhalis, Mycoplasma pneumoniae, Staphylococcus aureus and Streptococcus pneumoniae.

April 2019

DAPTOMYC, PELLIMYCIN, DABIMYCIN, DAPTOMYCIN NHPL, DAPTOMYCIN NEO HEALTH, APO-DAPTOMYCIN

Evaluation commenced: 29 Mar 2018

Registration decision: 18 Mar 2019

Date registered: 23 Apr 2019

Approval time: 204 working days (255)

Daptomycin

Neo Health (Australia) Pty Ltd

New generic medicine

DAPTOMYC, PELLIMYCIN, DABIMYCIN, DAPTOMYCIN NHPL, DAPTOMYCIN NEO HEALTH, APO-DAPTOMYCIN (powder for injection) are indicated for the treatment of adults and paediatric patients (1 to 17 years of age) with complicated skin and skin structure infections (cSSSI) who require parenteral therapy and who have intolerance to alternative agents (especially penicillin allergy) or who have failed on other therapy, and when caused by organisms known to be susceptible to daptomycin.

DAPTOMYC, PELLIMYCIN, DABIMYCIN, DAPTOMYCIN NHPL, DAPTOMYCIN NEO HEALTH, APO-DAPTOMYCIN (powder for injection) are also indicated for Staphylococcus aureus bloodstream infections (bacteraemia), including right-sided native valve infective endocarditis (RIE), caused by methicillin-susceptible and methicillin-resistant isolates. The efficacy of daptomycin in patients with prosthetic heart valves or in left-sided endocarditis due to Staphylococcus aureus has not been demonstrated. In the setting of Staphylococcus aureus bacteraemia (SAB), if a focus of infection is diagnosed as left-sided endocarditis after daptomycin therapy has been initiated, then consideration should be given to instituting alternative antibacterial therapy.

Daptomycin is active against Gram positive bacteria only. In mixed infections where Gram negative and/or certain types of anaerobic bacteria are suspected, Daptomycin should be coadministered with appropriate antibacterial agent(s).

Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Daptomycin is not indicated for the treatment of pneumonia.

OXYBUTYNIN ARW, OXYBUTYNIN TIH, OXYBUPAN first generic

Evaluation commenced: 30 Apr 2018

Registration decision: 18 Mar 2019

Date registered: 12 Apr 2019

Approval time: 180 working days (255)

oxybutynin hydrochloride

Arrow Pharma Pty Ltd

New generic medicine

OXYBUTYNIN ARW, OXYBUTYNIN TIH, OXYBUPAN (tablets) is indicated for the treatment of detrusor over-activity where conservative measures have failed.

FINGOLIS

Evaluation commenced: 31 May 2018

Registration decision: 4 Apr 2019

Date registered: 9 Apr 2019

Approval time: 172 working days (255)

fingolimod hydrochloride

Plunkett Consulting Pty Ltd

New generic medicine

FINGOLIS (capsules) is indicated for the treatment of Relapsing Remitting Multiple Sclerosis and Secondary Progressive Multiple Sclerosis with super imposed relapses to delay the progression of physical disability and reduce the frequency of relapse.

AMOXICILLIN MLABS, AMOXICILLIN B&B, AMOXICILLIN MLPL

Evaluation commenced: 31 May 2018

Registration decision: 7 Mar 2019

Date registered: 8 Apr 2019

Approval time: 153 working days (255)

amoxicillin trihydrate

Micro Labs Pty Ltd

New generic medicine

AMOXICILLIN MLABS, AMOXICILLIN B&B, AMOXICILLIN MLPL (powder for oral suspension) are indicated for the treatment of the following infections due to susceptible strains of sensitive organisms:

Note: Therapy should be guided by bacteriological studies, including sensitivity tests, and by clinical response. However, in emergency cases where the causative organism has not been identified, therapy with amoxicillin may be useful. Clinical judgement will decide whether combination with another antibiotic would provide a sufficiently broad spectrum of activity pending sensitivity test results.

Skin and Skin Structure

Staphylococcus, non-penicillinase producing; Streptococcus; E.coli.

Respiratory (Acute and Chronic)

H.influenzae, Streptococcus; S.pneumoniae; staphylococcus, non-penicillinase-producing; E.coli.

Genitourinary Tract (complicated and uncomplicated, Acute and Chronic)

E.coli, P.mirabilis and S.faecalis.

Gonorrhoea

N.gonorrhoeae (non-penicillinase producing).

Prophylaxis of endocarditis

AMOXICILLIN MLABS, AMOXICILLIN B&B, AMOXICILLIN MLPL (powder for oral suspension bottle pack) may be used for the prophylaxis of bacterial endocarditis in individuals at particular risk, such as those with a prosthetic heart valve or those who have previously had endocarditis.

TERIFLUNOMIDE-REDDY'S, TERIFLUNOMIDE-DRLA, TERIFLUNOMIDE-RZ, TERIFLUNOMIDE-DR.REDDY'S

Evaluation commenced: 29 Jun 2018

Registration decision: 3 Apr 2019

Date registered: 8 Apr 2019

Approval time: 150 working days (255)

teriflunomide

Dr Reddys Laboratories Australia Pty Ltd

New generic medicine

TERIFLUNOMIDE-REDDY'S, TERIFLUNOMIDE-DRLA, TERIFLUNOMIDE-RZ, TERIFLUNOMIDE-DR.REDDY'S (tablets) are indicated for the treatment of patients with relapsing forms of Multiple Sclerosis to reduce the frequency of clinical relapses and to delay the progression of physical disability.

MUPIROCIN NASAL OINTMENT (MEDICIANZ), MUPIROCIN NASAL OINTMENT (MEDSURGE)

Evaluation commenced: 28 Feb 2018

Registration decision: 14 Dec 2018

Date registered: 5 Apr 2019

Approval time: 156 working days (255)

mupirocin calcium

Medicianz Healthcare Pty Ltd

New generic medicine

MUPIROCIN NASAL OINTMENT (MEDICIANZ), MUPIROCIN NASAL OINTMENT (MEDSURGE) (ointment) are indicated for the elimination of nasal carriage of staphylococci, including methicillin resistant Staphylococcus aureus (MRSA).

March 2019

VORIZOLE PFS GPPL, ZOLENS PFS, VORIZOLE PFS, VZOLE PFS, VORICONAZOLE PFS GenPar, VORICONAZOLE PFS first generic

Evaluation commenced: 3 Oct 2017

Registration decision: 19 Mar 2019

Date registered: 22 Mar 2019

Approval time: 125 working days (255)

voriconazole

Generic Partners Pty Ltd

New generic medicine

VORIZOLE PFS GPPL, ZOLENS PFS, VORIZOLE PFS, VZOLE PFS, VORICONAZOLE PFS GenPar, VORICONAZOLE PFS (powder for oral suspension) are indicated for treatment of the following fungal infections:

  • Invasive aspergillosis
  • Serious Candida infections (including C. krusei), including oesophageal and systemic Candida infections (hepatosplenic candidiasis, disseminated candidiasis, candidaemia).
  • Serious fungal infections caused by Scedoosporium spp and Fusarium spp.
  • Other serious fungal infections, in patients intolerant of, or refractory to, other therapy.
  • Prophylaxis in patients who are at high risk of developing invasive fungal infections. The indication is based on studies including patients undergoing haematopoietic stem cell transplantation.

ATX TELMISARTAN, TELMISARTAN RY, TELMISARTAN GXP, G-SARTAN, TELMISARTAN GPPL, TELMISARTAN JL

Evaluation commenced: 31 Oct 2017

Registration decision: 7 Mar 2019

Date registered: 14 Mar 2019

Approval time: 170 working days (255)

telmisartan

Generic Partners Pty Ltd

New generic medicine

ATX TELMISARTAN, TELMISARTAN RY, TELMISARTAN GXP, G-SARTAN, TELMISARTAN GPPL, TELMISARTAN JL (tablets) are indicated for treatment of hypertension and prevention of cardiovascular morbidity and mortality in patients 55 years or older with coronary artery disease, peripheral artery disease, previous stroke, transient ischaemic attack or high risk diabetes with evidence of end organ damage.

G-SARTAN HCT, TELMISARTAN HCTZ JL, TELMISARTAN HCTZ GXP, ATX TELMISARTAN HCT, TELMISARTAN HCTZ RY, TELMISARTAN HCTZ GPPL

Evaluation commenced: 31 Oct 2017

Registration decision: 6 Mar 2019

Date registered: 14 Mar 2019

Approval time: 187 working days (255)

telmisartan; hydrochlorothiazide

Generic Partners Pty Ltd

New generic medicine

Telmisartan and hydrochlorothiazide (tablets) are indicated for the treatment of hypertension. Treatment should not be initiated with these combinations.

HYRIMOZ

Evaluation commenced: 30 Aug 2017

Registration decision: 23 Aug 2018

Date registered: 1 Mar 2019

Approval time: 205 working days (255)

adalimumab

Sandoz Pty Ltd

New biosimilar medicine

HYRIMOZ (solution for injection) is indicated for the treatment of:

Rheumatoid Arthritis
  • HYRIMOZ is indicated for reducing signs and symptoms, as well as inhibiting the progression of structural damage in adult patients with moderate to severely active rheumatoid arthritis. This includes the treatment of patients with recently diagnosed moderate to severely active disease who have not received methotrexate. HYRIMOZ can be used alone or in combination with methotrexate.
Juvenile Idiopathic Arthritis
Polyarticular Juvenile Idiopathic Arthritis
  • HYRIMOZ in combination with methotrexate is indicated for reducing the signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older who have had an inadequate response to one or more disease modifying anti-rheumatic drugs (DMARDs). HYRIMOZ can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.
Enthesitis-Related Arthritis
  • HYRIMOZ is indicated for the treatment of enthesitis-related arthritis in children, who have had an inadequate response to, or who are intolerant to, conventional therapy.
Psoriatic Arthritis
  • HYRIMOZ is indicated for the treatment of signs and symptoms, as well as inhibiting the progression of structural damage, of moderate to severely active psoriatic arthritis in adult patients where response to previous DMARDs has been inadequate.
Ankylosing Spondylitis
  • HYRIMOZ is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis.
Crohn's Disease in Adults and Children (≥6 years)
  • HYRIMOZ is indicated for the treatment of moderate to severe Crohn's disease, to reduce the signs and symptoms of the disease and to induce and maintain clinical remission in patients; who have had an inadequate response to conventional therapies or, who have lost response to or are intolerant to infliximab.
Ulcerative colitis
  • HYRIMOZ is indicated for the treatment of moderate to severe ulcerative colitis in adult patients who have had an inadequate response to conventional therapy or who are intolerant to or have medical contraindications for such therapies. Patients should show a clinical response within 8 weeks of treatment to continue treatment beyond that time.
Psoriasis in Adults and Children
  • HYRIMOZ is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.
  • HYRIMOZ is indicated for the treatment of severe chronic plaque psoriasis in children and adolescent patients from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapy.
Hidradenitis Suppurativa in Adults and Adolescents (from 12 years of age)
  • HYRIMOZ is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in patients with an inadequate response to conventional systemic hidradenitis suppurativa therapy.
Uveitis
  • HYRIMOZ is indicated for the treatment of non-infectious intermediate, posterior and pan-uveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid sparing, or in whom corticosteroid treatment is inappropriate.

February 2019

TERIFLUNOMIDE SANDOZ, TERIFLUNOMIDE HX

Evaluation commenced: 3 Apr 2018

Registration decision: 20 Feb 2019

Date registered: 26 Feb 2019

Approval time: 180 working days (255)

teriflunomide

Sandoz Pty Ltd

New generic medicine

TERIFLUNOMIDE SANDOZ, TERIFLUNOMIDE HX (film coated tablets) are indicated for the treatment of patients with relapsing forms of Multiple Sclerosis to reduce the frequency of clinical relapses and to delay the progression of physical disability.

PHARMACOR EZETIMIBE SIMVASTATIN, AKM-EZETIMIBE SIMVASTATIN

Evaluation commenced: 28 Feb 2018

Registration decision: 11 Feb 2019

Date registered: 18 Feb 2019

Approval time: 182 working days (255)

simvastatin; ezetimibe

Pharmacor Pty Ltd

New generic medicine

PHARMACOR EZETIMIBE SIMVASTATIN, AKM-EZETIMIBE SIMVASTATIN (tablets) are indicated in adults (aged ≥18 years) for:

Prevention of Cardiovascular Disease

In patients with coronary heart disease (CHD) and a history of acute coronary syndrome (ACS) taking their maximum tolerated dose of simvastatin and in need of additional lowering of LDL-C in the expectation of a modest further reduction in the risk of cardiovascular events following at least one year of therapy.

Primary Hypercholesterolaemia

As adjunctive therapy to diet in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia or mixed hyperlipidaemia where use of a combination product is appropriate:

  • Patients not appropriately controlled with a statin or ezetimibe alone.
  • Patients already treated with a statin and ezetimibe.
Homozygous Familial Hypercholesterolaemia (HoFH)

In patients with HoFH. Patients may also receive adjunctive treatments (e.g., LDL apheresis).

PHARMACOR EZETIMIBE SIMVASTATIN, AKM-EZETIMIBE SIMVASTATIN (tablets) are also indicated Children and Adolescents (aged 10-17 years; pubertal status: boys Tanner Stage II and above and girls who are at least one year post-menarche) for:

Heterozygous Familial Hypercholesterolaemia (HeFH)

As adjunctive therapy to diet in adolescent patients (10-17 years old) with heterozygous familial hypercholesterolaemia where use of a combination product is appropriate:

  • Patients not appropriately controlled with a statin or ezetimibe alone.
  • Patients already treated with a statin and ezetimibe.
Homozygous Familial Hypercholesterolaemia (HoFH)

In adolescent patients (10-17 years old) with HoFH. Patients may also receive adjunctive treatments (e.g., LDL apheresis).

TERIFLUNOMIDE-AX, TERIFLUNOMIDE APOTEX

Evaluation commenced: 2 Jan 2018

Registration decision: 1 Feb 2019

Date registered: 14 Feb 2019

Approval time: 242 working days (255)

teriflunomide

Apotex Pty Ltd

New generic medicine

TERIFLUNOMIDE-AX, TERIFLUNOMIDE APOTEX are indicated for the treatment of patients with relapsing forms of Multiple Sclerosis to reduce the frequency of clinical relapses and to delay the progression of physical disability.

APO-GEFITINIB, GEFITINIB APOTEX first generic

Evaluation commenced: 30 Apr 2018

Registration decision: 6 Feb 2019

Date registered: 14 Feb 2019

Approval time: 176 working days (255)

gefitinib

Apotex Pty Ltd

New generic medicine

APO-GEFITINIB, GEFITINIB APOTEX (film coated tablets) is indicated for the treatment of patients with locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) whose tumours express activating mutations of the epidermal growth factor receptor (EGFR) tyrosine kinase.

GTA-ONDANSETRON, PTIN-ONDANSETRON, Ipca-ONDANSETRON, ONDANSETRON APOTEX, TN-ONDANSETRON, PIP-ONDANSETRON

Evaluation commenced: 4 Apr 2018

Registration decision: 14 Jan 2019

Date registered: 1 Feb 2019

Approval time: 151 working days (255)

ondansetron hydrochloride dihydrate

Apotex Pty Ltd

New generic medicine

GTA-ONDANSETRON, PTIN-ONDANSETRON, Ipca-ONDANSETRON, ONDANSETRON APOTEX, TN-ONDANSETRON, PIP-ONDANSETRON (tablets) are indicated for the prevention and treatment of nausea and vomiting induced by cytotoxic therapy and radiotherapy.

January 2019

ONTRUZANT

Evaluation commenced: 1 Feb 2018

Registration decision: 21 Dec 2018

Date registered: 9 Jan 2019

Approval time: 179 working days (255)

trastuzumab

Samsung Bioepis AU Pty Ltd

New biosimilar medicine

ONTRUZANT (powder for injection) is indicated for:

Early Breast Cancer

ONTRUZANT is indicated for the treatment of HER2-positive early breast cancer following surgery, and in association with chemotherapy and, if applicable, radiotherapy.

Locally Advanced Breast Cancer

ONTRUZANT is indicated for the treatment of HER2-positive locally advanced breast cancer in combination with neoadjuvant chemotherapy followed by adjuvant ONTRUZANT

Metastatic Breast Cancer

ONTRUZANT is indicated for the treatment of patients with metastatic breast cancer who have tumours that overexpress HER2:

  • as monotherapy for the treatment of those patients who have received one or more chemotherapy regimens for their metastatic disease;
  • in combination with taxanes for the treatment of those patients who have not received chemotherapy for their metastatic disease; or
  • in combination with an aromatase inhibitor for the treatment of post-menopausal patients with hormone-receptor positive metastatic breast cancer.
Advanced Gastric Cancer

Ontruzant is indicated in combination with cisplatin and either capecitabine or 5-FU for the treatment of patients with HER2 positive advanced adenocarcinoma of the stomach or gastro-oesophageal junction who have not received prior anti-cancer treatment for their metastatic disease.

PHARMACOR CINACALCET, AKM CINACALCET

Evaluation commenced: 30 Nov 2017

Registration decision: 24 Dec 2018

Date registered: 8 Jan 2019

Approval time: 221 working days (255)

cinacalcet hydrochloride

Pharmacor Pty Ltd

New generic medicine

PHARMACOR CINACALCET, AKM CINACALCET (film-coated tablets) may be used to treat the biochemical manifestations of secondary hyperparathyroidism in patients with end stage renal disease, receiving dialysis. PHARMACOR CINACALCET, AKM CINACALCET should be used as adjunctive therapy.

PHARMACOR CINACALCET, AKM CINACALCET is also indicated for the treatment of hypercalcaemia in patients with parathyroid carcinoma.

PHARMACOR CINACALCET, AKM CINACALCET may also be used to treat the biochemical manifestations of primary hyperparathyroidism in patients for whom parathyroidectomy is not a treatment option.

TERIFLUNOMIDE AGH, TERIFLUNOMIDE ALEMBIC, TERILEX, TERIFLUNOMIDE APPL, TERIFLUNOMIDE APL, TERILEMBIC TERIFLUNOMIDE, TERIBIC, TERIFLUNOMIDE APGH, TERIFLUNOMIDE ALEM, TERIFLUNOMIDE APEL, TERIFLUNOMIDE APAL, TERIFLUGIO, TERIFLUNOMIDE AGL, TERIFLUNOMIDE AGHL, TERIFLUNOMIDE APA, TERIMIDE first generic

Evaluation commenced: 28 Feb 2018

Registration decision: 4 Dec 2018

Date registered: 7 Jan 2019

Approval time: 161 working days (255)

teriflunomide

Alembic Pharmaceuticals Australia Pty Ltd

New generic medicine

TERIFLUNOMIDE AGH, TERIFLUNOMIDE ALEMBIC, TERILEX, TERIFLUNOMIDE APPL, TERIFLUNOMIDE APL, TERILEMBIC TERIFLUNOMIDE, TERIBIC, TERIFLUNOMIDE APGH, TERIFLUNOMIDE ALEM, TERIFLUNOMIDE APEL, TERIFLUNOMIDE APAL, TERIFLUGIO, TERIFLUNOMIDE AGL, TERIFLUNOMIDE AGHL, TERIFLUNOMIDE APA, TERIMIDE (film-coated tablets) are indicated for the treatment of patients with relapsing forms of Multiple Sclerosis to reduce the frequency of clinical relapses and to delay the progression of physical disability.