Australia · Therapeutic Goods Administration · Biosimilars
Review target
-
Not published
Legal time limit
255 working days
regulation
Steps
4
4 requirements
Application fee
-
A biosimilar is a version of a biological medicine already registered in Australia. The application meets the same requirements as other prescription medicines and uses the same milestone process. Comparability studies against the reference medicine are central. A biological medicine shown to be highly similar to a registered reference biological medicine.
1. Pre-submission planning form; 2. Dossier submission and acceptance check; 3. Evaluation rounds; 4. Delegate decision.
Outcome: Registration in the Australian Register of Therapeutic Goods.
Legal basis: Therapeutic Goods Act 1989, section 23; Therapeutic Goods Regulations 1990, regulation 16C
Each box is one step; arrows show the order. Dashed boxes happen only in some cases; the orange arrows go back (for example after questions).
Official step durations
In order, with the official target for each step
What the applicant must provide or meet
Targets, not actual review times
| Legal time limitregulation. Same legal limit as other prescription medicine registrations. | 255 working days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| No fees published. |
Other routes in Australia: Registration of a new prescription medicine (standard pathway), Extension of indications and major variations of a registered prescription medicine, Comparable overseas regulator report-based process, approach A, Comparable overseas regulator report-based process, approach B, Priority review pathway for prescription medicines, Provisional approval pathway for prescription medicines, Orphan drug designation, Access Consortium work-sharing, Project Orbis collaborative oncology review. See all routes on the Australia page or explore them in the Regulatory section.
Not legal or regulatory advice. Check the current official rules before you act. This summary was checked against the official laws, regulations and regulator guidance on October 3, 2026 (6 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.