You are here

Prescription medicines: registration of new generic medicines and biosimilar medicines

5 May 2020

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, 2020

Previous years

2019 2018 2017

April 2020

AKM GLICLAZIDE, PHARMACOR GLICLAMIRON, PHARMACOR GLICLARON, PHARMACOR GLICLAZIDE, PHARMACOR GLICLAZIDE MR

Evaluation commenced: 31 May 2019

Registration decision: 27 Mar 2020

Date registered: 29 Apr 2020

Approval time: 146 working days (255)

gliclazide

Pharmacor Pty Ltd

New generic medicine

AKM GLICLAZIDE, PHARMACOR GLICLAMIRON, PHARMACOR GLICLARON, PHARMACOR GLICLAZIDE, PHARMACOR GLICLAZIDE MR (modified release tablet) are indicated for the treatment of type II diabetes in association with dietary measures when dietary measures alone are inadequate to control blood glucose.

During controlled clinical trials in patients with type II diabetes, a modified release formulation of gliclazide (30 mg - 120 mg), taken as a single daily dose, was shown to be effective long term in controlling blood glucose levels, based on monitoring of HbA1c.

DARUNAVIR JUNO

Evaluation commenced: 1 Jul 2019

Registration decision: 15 Apr 2020

Date registered: 22 Apr 2020

Approval time: 154 working days (255)

darunavir

Accelagen Pty Ltd

New generic medicine

Adult patients

DARUNAVIR JUNO (film coated tablets) (with low dose ritonavir as a pharmacokinetic enhancer) is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adult patients.

Paediatric patients

DARUNAVIR JUNO (with low dose ritonavir as a pharmacokinetic enhancer) is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV) infection in treatment-experienced paediatric patients aged 6 years and older, weighing at least 20 kg.

BPA-FLECAINIDE

Evaluation commenced: 31 May 2019

Registration decision: 20 Mar 2020

Date registered: 15 Apr 2020

Approval time: 164 working days (255)

flecainide acetate

Beximco Pharmaceuticals Australia Pty Ltd

New generic medicine

BPA-FLECAINIDE (tablets) is indicated for:

Supraventricular arrhythmias:
  • due to pre-excitation syndromes, e.g. Wolff-Parkinson-White and Lown-Ganong-Levine syndromes
  • due to dual AV nodal pathways in patients with debilitating symptoms
  • paroxysmal atrial fibrillation/flutter (PAF) associated with disabling symptoms

Although BPA-FLECAINIDE may be effective in supraventricular arrhythmias in patients with structural heart disease, its use has been associated with life-threatening and occasionally fatal ventricular arrhythmias. In these patients, particularly in the presence of impaired left ventricular function, BPA-FLECAINIDE should be used with extreme caution, preferably after other antiarrhythmic drugs have been tried or considered inappropriate.

Use of BPA-FLECAINIDE in chronic atrial fibrillation has not been adequately studied and is not recommended.

Life threatening ventricular arrhythmias not controlled by other drugs.

BPA-FLECAINIDE tablets are used for continuous maintenance of normal rhythm following initial oral or intravenous (available in other brands) therapy or conversion by other means.

Prescribers should also consult the 'Special Warnings and Precautions for Use' section of this Product Information.

CIPLA PREGABALIN, CIPGABLIN, PREGACIPLIN

Evaluation commenced: 31 May 2019

Registration decision: 6 Apr 2020

Date registered: 15 Apr 2020

Approval time: 157 working days (255)

pregabalin

Cipla Australia Pty Ltd

New generic medicine

CIPLA PREGABALIN, CIPGABLIN, PREGACIPLIN (capsules) are indicated for the treatment of neuropathic pain in adults.

CIPLA PREGABALIN, CIPGABLIN, PREGACIPLIN are indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.

AMBRISENTAN MYLAN, AMBRISENTAN MYL

Evaluation commenced: 11 May 2018

Registration decision: 14 Mar 2019

Date registered: 1 Apr 2020

Approval time: 164 working days (255)

ambrisentan

Alphapharm Pty Ltd

New generic medicine

AMBRISENTAN MYLAN, AMBRISENTAN MYL (film-coated tablets) are indicated for treatment of:

  • idiopathic pulmonary arterial hypertension (PAH),
  • pulmonary arterial hypertension associated with connective tissue disease (PAHCTD), in patients with WHO functional class II, III or IV symptoms.

Ambrisentan in combination with Tadalafil is indicated for the treatment of WHO Group I pulmonary arterial hypertension in patients with WHO functional class II, III or IV symptoms.

March 2020

DAPTOMYCIN ACCORD, DAPTOMYCIN INTAS

Evaluation commenced: 31 May 2019

Registration decision: 13 Mar 2020

Date registered: 24 Mar 2020

Approval time: 165 working days (255)

daptomycin

Accord Healthcare Pty Ltd

New generic medicine

DAPTOMYCIN ACCORD, DAPTOMYCIN INTAS (powder for injection) 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 co- administered 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.

Adult patients (18 years of age and over)
Complicated Skin and Skin Structure Infections

Daptomycin is indicated for the treatment of adults (18 years of age and over) 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.

Staphylococcus aureus Bloodstream Infections (Bacteraemia)

Daptomycin is indicated in adults (18 years of age and over) 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.

Paediatric patients (1 to 17 years of age)

Daptomycin is not indicated for treatment of patients less than 1 year of age.

Daptomycin has not been studied in treatment of infective endocarditis in children.

Complicated Skin and Skin Structure Infections

Daptomycin is indicated for the treatment of patients aged 1 to 17 years 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 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.

Staphylococcus aureus Bloodstream Infections (Bacteraemia)

Daptomycin is indicated in paediatric patients (1 to 17 years of age) with Staphylococcus aureus bacteraemia not due to pneumonia, caused by daptomycin-susceptible isolates. Empiric treatment should be reviewed based on the results of susceptibility testing. Prescribing should be in accordance with nationally or locally-endorsed guidelines for the treatment of Staphylococcus aureus bacteraemia.

SOLIFENACIN MYLAN

Evaluation commenced: 29 Feb 2016

Registration decision: 12 Dec 2016

Date registered: 19 Mar 2020

Approval time: 151 working days (255)

solifenacin succinate

Alphapharm Pty Ltd

New generic medicine

SOLIFENACIN MYLAN (tablet) is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency or increased urinary frequency.

MSN-LURASIDONE first generic

Evaluation commenced: 1 Jul 2019

Registration decision: 13 Mar 2020

Date registered: 17 Mar 2020

Approval time: 131 working days (255)

lurasidone hydrochloride

Accelagen Pty Ltd

New generic medicine

MSN-LURASIDONE (film-coated tablet) is indicated for the treatment of schizophrenia in adults and adolescents (aged 13 to 17 years).

DESFLURANE SANDOZ

Evaluation commenced: 31 Mar 2017

Registration decision: 13 Dec 2017

Date registered: 12 Mar 2020

Approval time: 134 working days (255)

desflurane

Sandoz Pty Ltd

New generic medicine

DESFLURANE SANDOZ (solution for inhalation) is indicated as an inhalation agent for maintenance of anaesthesia. DESFLURANE SANDOZ is not recommended for mask induction of anaesthesia because of a high incidence of moderate to severe upper airway adverse events.

SEVOFLURANE SANDOZ

Evaluation commenced: 31 Mar 2017

Registration decision: 27 Feb 2018

Date registered: 12 Mar 2020

Approval time: 145 working days (255)

sevoflurane

Sandoz Pty Ltd

New generic medicine

SEVOFLURANE SANDOZ (solution for inhalation) may be used for induction and maintenance of general anaesthesia in adult and paediatric patients undergoing surgery.

IRINOTECAN ACCORD, IRINOTECAN INTAS

Evaluation commenced: 31 May 2019

Registration decision: 2 Mar 2020

Date registered: 5 Mar 2020

Approval time: 178 working days (255)

irinotecan hydrochloride trihydrate

Accord Healthcare Pty Ltd

New generic medicine

IRINOTECAN ACCORD, IRINOTECAN INTAS (concentrated solution for injection) is indicated as a component of first-line therapy for patients with metastatic carcinoma of the colon or rectum. Irinotecan hydrochloride is also indicated for patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial therapy.

NALOXONE RMB, NALOXONE SXP, NALOXONE TLB

Evaluation commenced: 2 Apr 2019

Registration decision: 28 Feb 2020

Date registered: 5 Mar 2020

Approval time: 114 working days (255)

naloxone hydrochloride dihydrate

Southern Cross Pharma Pty Ltd

New generic medicine

NALOXONE RMB, NALOXONE SXP, NALOXONE TLB (solution for injection) is indicated for the complete or partial reversal of opioid depression, including respiratory depression, induced by natural and synthetic opioids including propoxyphene, methadone, codeine, morphine and heroin, and the mixed opioid agonist-antagonist analgesics such as pentazocine. Naloxone is also indicated for the diagnosis of suspected acute opioid overdosage.

POSACONAZOLE SANDOZ first generic

Evaluation commenced: 8 Jul 2019

Registration decision: 24 Feb 2020

Date registered: 3 Mar 2020

Approval time: 117 working days (255)

posaconazole

Sandoz Pty Ltd

New generic medicine

POSACONAZOLE SANDOZ (modified release tablet) is indicated for use in the treatment of the following invasive fungal infections in patients 13 years of age or older:

  • Invasive aspergillosis in patients intolerant of, or with disease that is refractory to, alternative therapy.
  • Fusariosis, zygomycosis, coccidioidomycosis, chromoblastomycosis, and mycetoma in patients intolerant of, or with disease that is refractory to, alternative therapy.

POSACONAZOLE SANDOZ is also indicated for the prophylaxis of invasive fungal infections among patients 13 years of age and older, who are at high risk of developing these infections, such as patients with prolonged neutropenia or haematopoietic stem cell transplant (HSCT) recipients.

February 2020

APO-TAMSULOSIN SR, BLOOMS THE CHEMIST TAMSULOSIN SR, TAMSULOSIN ANS SR, TAMSULOSIN SCP SR

Evaluation commenced: 31 Jan 2019

Registration decision: 19 Nov 2019

Date registered: 25 Feb 2020

Approval time: 159 working days (255)

tamsulosin hydrochloride

Southern Cross Pharma Pty Ltd

New generic medicine

APO-TAMSULOSIN SR, BLOOMS THE CHEMIST TAMSULOSIN SR, TAMSULOSIN ANS SR, TAMSULOSIN SCP SR (modified release tablet) are indicated for the relief of lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH).

PEMETREXED-AFT

Evaluation commenced: 30 Nov 2018

Registration decision: 10 Feb 2020

Date registered: 25 Feb 2020

Approval time: 254 working days (255)

pemetrexed disodium hemipentahydrate

AFT Pharmaceuticals Pty Ltd

New generic medicine

Malignant Pleural Mesothelioma

PEMETREXED-AFT (powder for injection), in combination with cisplatin, is indicated for the treatment of patients with malignant pleural mesothelioma.

Non-Small Cell Lung Cancer

PEMETREXED-AFT in combination with cisplatin is indicated for initial treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.

PEMETREXED-AFT as monotherapy is indicated for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer other than predominantly squamous cell histology after prior platinum-based chemotherapy.

SODIUM NITROPRUSSIDE, SODIUM NITROPRUSSIDE B&B, SODIUM NITROPRUSSIDE MEDSURGE, SODIUM NITROPRUSSIDE MICRO MEDICS first generic

Evaluation commenced: 8 May 2019

Registration decision: 13 Feb 2020

Date registered: 25 Feb 2020

Approval time: 149 working days (255)

sodium nitroprusside

Micro Labs Pty Ltd

New generic medicine

SODIUM NITROPRUSSIDE, SODIUM NITROPRUSSIDE B&B, SODIUM NITROPRUSSIDE MEDSURGE, SODIUM NITROPRUSSIDE MICRO MEDICS (concentrated solution for injection) are indicated for:

  • Immediate reduction of blood pressure in patients with hypertensive crises. Concomitant oral antihypertensive medication should be started while the hypertensive emergency is being brought under control with sodium nitroprusside.
  • Producing controlled hypotension during anaesthesia in order to reduce bleeding in surgical procedures where surgeon and anaesthetist deem it appropriate.
  • Short term therapy of cardiac failure, to enhance cardiac output and lower myocardial oxygen requirements. patients should be commenced on oral therapy as soon as possible.

TALMINEX first generic

Evaluation commenced: 31 Jan 2019

Registration decision: 13 Feb 2020

Date registered: 25 Feb 2020

Approval time: 163 working days (255)

oseltamivir phosphate

Accelagen Pty Ltd

New generic medicine

TALMINEX (capsules) is indicated for the treatment of infections due to influenza A and B viruses in adults and children including full-term neonates. Treatment should commence as soon as possible, but no later than 48 hours after the onset of the initial symptoms of infection.

TALMINEX is indicated for the prevention of influenza in adults and children aged 1 year and older. Vaccination is the preferred method of routine prophylaxis against infection with influenza virus.

APO-PACLITAXEL, PACLITAXEL APOTEX

Evaluation commenced: 30 Apr 2018

Registration decision: 6 Feb 2020

Date registered: 14 Feb 2020

Approval time: 253 working days (255)

paclitaxel

Apotex Pty Ltd

New generic medicine

Metastatic Breast Cancer

Albumin-bound APO-PACLITAXEL, PACLITAXEL APOTEX (powder for injection) are indicated for the treatment of metastatic carcinoma of the breast after failure of anthracycline therapy.

METARAMINOL MYX

Evaluation commenced: 30 Nov 2018

Registration decision: 13 Feb 2020

Date registered: 14 Feb 2020

Approval time: 162 working days (255)

metaraminol tartrate

Mayne Pharma International Pty Ltd

New generic medicine

METARAMINOL MYX (solution for injection) is indicated for the prevention and treatment of the acute hypotensive state occurring with spinal anaesthesia; adjunctive treatment of hypotension due to haemorrhage, reactions to medications, surgical complications, and shock associated with brain damage due to tumour or trauma.

It may also be useful as an adjunct in the treatment of hypotension due to cardiogenic shock or septicaemia.

January 2020

BORTEZOMIB-AFT

Evaluation commenced: 31 Oct 2018

Registration decision: 14 Jan 2020

Date registered: 21 Jan 2020

Approval time: 253 working days (255)

bortezomib

AFT Pharmaceuticals Pty Ltd

New generic medicine

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

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

PIRAMAL DESFLURANE first generic

Evaluation commenced: 2 Apr 2019

Registration decision: 23 Dec 2019

Date registered: 21 Jan 2020

Approval time: 140 working days (255)

desflurane

Piramal Critical Care Pty Ltd

New generic medicine

PIRAMAL DESFLURANE (inhalation bottle) is indicated as an inhalation agent for maintenance of anaesthesia. Desflurane is not recommended for mask induction of anaesthesia because of a high incidence of moderate to severe upper airway adverse events.

VIZO-PF BIMATOPROST

Evaluation commenced: 1 Apr 2019

Registration decision: 13 Jan 2020

Date registered: 17 Jan 2020

Approval time: 119 working days (255)

bimatoprost

AFT Pharmaceuticals Pty Ltd

New generic medicine

VIZO-PF BIMATOPROST (eye drops) is indicated for the reduction of elevated intraocular pressure, or open angle glaucoma, as first line therapy or monotherapy or as adjunctive therapy to topical beta-blockers.

MSN-SOLIFENACIN

Evaluation commenced: 28 Feb 2019

Registration decision: 24 Sep 2019

Date registered: 10 Jan 2020

Approval time: 96 working days (255)

solifenacin succinate

Accelagen Pty Ltd

New generic medicine

MSN-SOLIFENACIN (film-coated tablet) is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency or increased urinary frequency.

JUNOMINE ER, PHENTERMINE JUNO ER first generic

Evaluation commenced: 30 Nov 2018

Registration decision: 2 Oct 2019

Date registered: 9 Jan 2020

Approval time: 134 working days (255)

phentermine hydrochloride

Juno PC Holdings Pty Limited

New generic medicine

JUNOMINE ER, PHENTERMINE JUNO ER (extended release tablet) is an anorectic agent indicated in the management of obesity as a short-term adjunct in a medically monitored comprehensive regimen of weight reduction based, for example, on exercise, diet (caloric/kilojoule restriction) and behaviour modification in obese patients with a body mass index (BMI) of 30 kg/m2 or greater.

The treatment with Phentermine can be initiated in overweight patients with a lower BMI (25 to 29.9 kg/m2), which increases the risk of morbidity from a number of disorders. Secondary organic causes of obesity should be excluded by diagnosis before prescribing this agent.