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Prescription medicines: registration of new generic medicines and biosimilar medicines

15 May 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

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.