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Prescription medicines: registration of new generic medicines and biosimilar medicines
14 April 2021
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.
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, 2021
March 2021
APX-DIENOGEST, DIENOGEST-STR, DINASANE 
Evaluation commenced: 30 Jun 2020
Registration decision: 26 Mar 2021
Date registered: 30 Mar 2021
Approval time: 148 (255 working days)
dienogest
Arrow Pharma Pty Ltd
New generic medicine
APX-DIENOGEST, DIENOGEST-STR, DINASANE (tablet) is indicated for the treatment of endometriosis.
MSN DASATINIB
Evaluation commenced: 3 Jun 2020
Registration decision: 19 Mar 2021
Date registered: 25 Mar 2021
Approval time: 154 (255 working days)
dasatinib
Accelagen Pty Ltd
New generic medicine
MSN DASATINIB (tablet) is indicated for the treatment of adults aged 18 years or over with:
- newly diagnosed Philadelphia chromosome positive (Ph+) chronic myeloid leukaemia in the chronic phase.
- chronic, accelerated or myeloid or lymphoid blast phase chronic myeloid leukaemia with resistance or intolerance to prior therapy including imatinib.
- newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia integrated with chemotherap.
- Philadelphia chromosome positive acute lymphoblastic leukaemia with resistance or intolerance to prior therapy.
MSN DASATINIB is indicated for the treatment of paediatric patients with:
- Ph+ CML in the chronic phase.
- newly diagnosed Ph+ ALL in combination with chemotherapy.
COLCINE, PHARMACOR COLCHICINE
Evaluation commenced: 2 Jun 2020
Registration decision: 15 Mar 2021
Date registered: 22 Mar 2021
Approval time: 149 (255 working days)
colchicine
Pharmacor Pty Ltd
New generic medicine
Relief of pain in acute gout. COLCINE, PHARMACOR COLCHICINE (tablet) should not be used unless NSAIDS are contraindicated, or have been used and found to lack analgesic efficacy or to have unacceptable side effects in the individual patient.
COLCINE, PHARMACOR COLCHICINE is not an analgesic and does not provide relief from other types of pain.
AKM DEFERASIROX FC, PHARMACOR DEFERASIROX FC
Evaluation commenced: 6 Apr 2020
Registration decision: 11 Feb 2021
Date registered: 22 Mar 2021
Approval time: 147 (255 working days)
deferasirox
Pharmacor Pty Ltd
New generic medicine
The treatment of chronic iron overload due to blood transfusions (transfusional haemosiderosis) in adults and paediatric patients 6 years and older. AKM DEFERASIROX FC, PHARMACOR DEFERASIROX FC (tablet) is also indicated for the treatment of chronic iron overload in paediatric patients aged 2 to 5 years who are unable to take desferrioxamine therapy or in whom desferrioxamine has proven ineffective.
AKM DEFERASIROX FC, PHARMACOR DEFERASIROX FC is also indicated for the treatment of chronic iron overload in patients with nontransfusion-dependent thalassemia syndromes aged 10 years and older.
DASATINIB-TEVA, TE-DASATINIB
Evaluation commenced: 11 May 2020
Registration decision: 11 Mar 2021
Date registered: 18 Mar 2021
Approval time: 163 (175 working days)
dasatinib
Teva Pharma Australia Pty Ltd
New generic medicine
DASATINIB-TEVA, TE-DASATINI (tablet) is indicated for the treatment of adults aged 18 years or over with:
- newly diagnosed Philadelphia chromosome positive (Ph+) chronic myeloid leukaemia in the chronic phase.
- chronic, accelerated or myeloid or lymphoid blast phase chronic myeloid leukaemia with resistance or intolerance to prior therapy including imatinib.
- newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia integrated with chemotherapy.
- Philadelphia chromosome positive acute lymphoblastic leukaemia with resistance or intolerance to prior therapy.
Dasatinib is indicated for the treatment of paediatric patients with:
- Ph+ CML in the chronic phase.
- newly diagnosed Ph+ ALL in combination with chemotherapy.
ICATIBANT MYLAN
Evaluation commenced: 4 Mar 2019
Registration decision: 20 Dec 2019
Date registered: 12 Mar 2021
Approval time: 158 (255 working days)
icatibant
Alphapharm Pty Ltd
New generic medicine
ICATIBANT MYLAN (solution for injection) is indicated for symptomatic treatment of acute attacks of hereditary angioedema (HAE) in adults with C1-esterase-inhibitor deficiency.
EFERAS
Evaluation commenced: 30 Apr 2020
Registration decision: 11 Feb 2021
Date registered: 12 Mar 2021
Approval time: 139 (255 working days)
deferasirox
Alphapharm Pty Ltd
New generic medicine
The treatment of chronic iron overload due to blood transfusions (transfusional haemosiderosis) in adults and paediatric patients 6 years and older. EFERAS (tablet) is also indicated for the treatment of chronic iron overload in paediatric patients aged 2 to 5 years who are unable to take desferrioxamine therapy or in whom desferrioxamine has proven ineffective.
EFERAS is also indicated for the treatment of chronic iron overload in patients with non-transfusion- dependent thalassemia syndromes aged 10 years and older.
TENOFOVIR EMTRICITABINE SANDOZ
Evaluation commenced: 2 Jan 2020
Registration decision: 18 Feb 2021
Date registered: 1 Mar 2021
Approval time: 172 (255 working days)
emtricitabine; tenofovir disoproxil succinate
Sandoz Pty Ltd
New generic medicine
Treatment of HIV-1 infection
TENOFOVIR, EMTRICITABINE SANDOZ (tablet) is indicated for the treatment of HIV infected adults over the age of 18 years, in combination with other antiretroviral agents.
Pre-Exposure Prophylaxis
TENOFOVIR, EMTRICITABINE SANDOZ is indicated in combination with safer sex practices for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults at high risk. This indication is based on clinical trials in men who have sex with men (MSM) at high risk for HIV-1 infection and in heterosexual serodiscordant couples (see section 5.1 Pharmacodynamic properties, Clinical trials).
February 2021
ALENAMI
Evaluation commenced: 31 Jul 2019
Registration decision: 22 Feb 2021
Date registered: 25 Feb 2021
Approval time: 141 (255 working days)
phentermine hydrochloride
Aspen Pharmacare Australia Pty Ltd
New generic medicine
ALENAMI (capsule) 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 ALENAMI 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.
SUNITINIB SUN
Evaluation commenced: 30 Apr 2020
Registration decision: 9 Feb 2021
Date registered: 22 Feb 2021
Approval time: 149 (255 working days)
sunitinib malate
Sun Pharma ANZ Pty Ltd
New generic medicine
SUNITINIB SUN (capsule) is indicated for:
- treatment of advanced renal cell carcinoma (RCC)
- treatment of gastrointestinal stromal tumour (GIST) after failure of imatinib mesilate treatment due to resistance or intolerance
- treatment of unresectable, well-differentiated pancreatic neuroendocrine tumours (pancreatic NET).
ABRILADA
Evaluation commenced: 2 Jun 2020
Registration decision: 8 Feb 2021
Date registered: 22 Feb 2021
Approval time: 148 (175 working days)
adalimumab
Pfizer Australia Pty Ltd
New biosimilar medicine
Rheumatoid Arthritis
ABRILADA (solution for injection) 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.
ABRILADA can be used alone or in combination with methotrexate.
Juvenile Idiopathic Arthritis
Polyarticular Juvenile Idiopathic Arthritis
ABRILADA 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 antirheumatic drugs (DMARDs). ABRILADA can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate
Enthesitis-Related Arthris
ABRILADA 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
ABRILADA 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
ABRILADA is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis.
Crohn's Disease in Adults and Children (6 years and above)
ABRILADA 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
ABRILADA 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. (see 5.1 PHARMACODYNAMIC PROPERTIES - CLINICAL TRIALS).
Psoriasis in Adults and Children
ABRILADA is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.
ABRILADA 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)
ABRILADA 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
ABRILADA is indicated for the treatment of non-infectious intermediate, posterior and panuveitis 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.
VARENICLINE SANDOZ
Evaluation commenced: 27 Feb 2020
Registration decision: 4 Dec 2020
Date registered: 16 Feb 2021
Approval time: 141 (255 working days)
varenicline citrate
Sandoz Pty Ltd
New generic medicine
VARENICLINE SANDOZ (tablet) is indicated as an aid to smoking cessation in adults over the age of 18 years.
VIRUPOS
Evaluation commenced: 2 Dec 2019
Registration decision: 5 Feb 2021
Date registered: 11 Feb 2021
Approval time: 123 (255 working days)
aciclovir
AFT Pharmaceuticals Pty Ltd
New generic medicine
VIRUPOS (eye ointment) is indicated for treatment of Herpes simplex keratitis.
TIGECYCLINE ACCORD, TIGECYCLINE INTAS
Evaluation commenced: 30 Apr 2020
Registration decision: 5 Feb 2021
Date registered: 11 Feb 2021
Approval time: 142 (255 working days)
tigecycline
Accord Healthcare Pty Ltd
New generic medicine
TIGECYCLINE ACCORD, TIGECYCLINE INTAS (powder for injection) is indicated for the treatment of the following infections in adults:
- Complicated skin and skin structure infections, including those with methicillin-resistant Staphylococcus aureus (MRSA), where there is suspected or proven resistance to, intolerance of, or there are co-morbidities preventing the use of, other available agents.
- Complicated intra-abdominal infections, where there is suspected or proven resistance to, intolerance of, or there are co-morbidities preventing the use of, other available agents.
BORTEZOMIB ACCORD, BORTEZOMIB INTAS
Evaluation commenced: 1 May 2019
Registration decision: 8 Jul 2020
Date registered: 9 Feb 2021
Approval time: 252 (255 working days)
bortezomib
Accord Healthcare Pty Ltd
New generic medicine
BORTEZOMIB ACCORD, BORTEZOMIB INTAS (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 ACCORD, BORTEZOMIB INTAS, 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 ACCORD, BORTEZOMIB INTAS is also indicated for the treatment of multiple myeloma patients who have received at least one prior therapy, and who have progressive disease.
BORTEZOMIB ACCORD, BORTEZOMIB INTAS in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma.
APO-CICLOSPORIN, CICLORAL, CICLOSPORIN GENPAR, CICLOSPORIN GPPL, CICLOSPORIN GXP, CICLOSPORIN-APOTEX, NELORIN, NERIN
Evaluation commenced: 31 Oct 2019
Registration decision: 5 Feb 2021
Date registered: 9 Feb 2021
Approval time: 147 (255 working days)
ciclosporin
Generic Partners Pty Ltd
New generic medicine
APO-CICLOSPORIN, CICLORAL, CICLOSPORIN GENPAR, CICLOSPORIN GPPL, CICLOSPORIN GXP, CICLOSPORIN-APOTEX, NELORIN, NERIN (soft capsule) is indicated:
- As an immunosuppressive agent for the prevention of graft rejection following kidney, liver and heart allogeneic transplantation.
- For induction and/or maintenance of remission in the nephrotic syndrome. APO-CICLOSPORIN, CICLORAL, CICLOSPORIN GENPAR, CICLOSPORIN GPPL, CICLOSPORIN GXP, CICLOSPORIN-APOTEX, NELORIN, NERIN is not a first-line agent. Its use should be restricted to occasions when steroids and cytostatic drugs have failed, or are not tolerated, or are considered inappropriate, and when renal function is unimpaired (see section 4.4 Special Warnings and Precautions for Use).
- For the treatment of severe, active rheumatoid arthritis in patients for whom classical slow-acting antirheumatic agents (including methotrexate) are inappropriate or ineffective.
- In patients with severe psoriasis in whom conventional therapy is ineffective or inappropriate and the disease has caused a significant interference with quality of life.
- For the treatment of severe atopic dermatitis when other treatment is ineffective or inappropriate.
Careful monitoring of all ciclosporin-treated patients is mandatory. APO-CICLOSPORIN, CICLORAL, CICLOSPORIN GENPAR, CICLOSPORIN GPPL, CICLOSPORIN GXP, CICLOSPORIN-APOTEX, NELORIN, NERIN should only be used by medical practitioners who are experienced in the use of immunosuppressive therapy (see SECTION 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE).
CILATIL, TADALAFIL ALPHAPHARM
Evaluation commenced: 31 Oct 2013
Registration decision: 2 Sep 2014
Date registered: 3 Feb 2021
Approval time: 135 (255 working days)
tadalafil
Alphapharm Pty Ltd
New generic medicine
CILATIL,TADALAFIL ALPHAPHARM (tablet) is indicated for the treatment of:
- erectile dysfunction (ED) in adult males
- moderate to severe lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) in adult males
January 2021
EZETIMIBE-SIMVASTATIN ALPHAPHARM, ZIMYBE
Evaluation commenced: 27 Mar 2013
Registration decision: 12 Nov 2013
Date registered: 11 Jan 2021
Approval time: 121 (255 working days)
ezetimibe; simvastatin
Alphapharm Pty Ltd
New generic medicine
Primary Hypercholesterolaemia
EZETIMIBE-SIMVASTATIN ALPHAPHARM, ZIMYBE (tablet) is indicated 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)
EZETIMIBE-SIMVASTATIN ALPHAPHARM, ZIMYBE is indicated in patients with HoFH. Patients may also receive adjunctive treatments (e.g., LDL apheresis).
EZETIMIBE ALPHAPHARM, MYLAN-EZETIMIBE
Evaluation commenced: 27 Mar 2013
Registration decision: 16 Oct 2013
Date registered: 11 Jan 2021
Approval time: 97 (255 working days)
ezetimibe
Alphapharm Pty Ltd
New generic medicine
Primary Hypercholesterolaemia
EZETIMIBE ALPHAPHARM, MYLAN-EZETIMIBE (tablet) administered alone, or with an HMG-CoA reductase inhibitor (statin), is indicated as adjunctive therapy to diet in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia.
Homozygous Familial Hypercholesterolaemia (HoFH)
EZETIMIBE ALPHAPHARM,MYLAN-EZETIMIBE administered with a statin, is indicated for patients with HoFH. Patients may also receive adjunctive treatments (e.g., LDL apheresis).
Homozygous Sitosterolaemia (Phytosterolaemia)
EZETIMIBE ALPHAPHARM, MYLAN-EZETIMIBE is indicated for the reduction of elevated sitosterol and campesterol levels in patients with homozygous familial sitosterolaemia.