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Prescription medicines: registration of new generic medicines and biosimilar medicines

11 February 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

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.