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Prescription medicines: registration of new generic medicines and biosimilar medicines
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.
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.
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, 2019
Evaluation commenced: 1 Feb 2018
Registration decision: 21 Dec 2018
Date registered: 9 Jan 2019
Approval time: 179 working days (255)
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)
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
Evaluation commenced: 28 Feb 2018
Registration decision: 4 Dec 2018
Date registered: 7 Jan 2019
Approval time: 161 working days (255)
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.