The government is now operating in accordance with the Guidance on Caretaker Conventions, pending the outcome of the 2025 federal election.
Access Biosimilars work-sharing
With the addition of the MHRA to the Access Consortium, the Consortium is looking to build on this success of the New Active Substance (NAS) and Generic Medicines work-sharing initiative and expand work-sharing to biosimilars.
The objective of the Biosimilars work-sharing initiative includes enabling Access Consortium members to exchange regulatory evaluation information, conduct joint assessments of biosimilar applications for marketing authorisation; and discuss emerging international regulatory issues with biosimilar medicinal products.
For more information about work-sharing and its benefits for sponsors, see Australia-Canada-Singapore-Switzerland-United Kingdom (Access) Consortium.
Biosimilars approved through work-sharing
No biosimilars have been approved through work-sharing as yet.
How to submit an application for Biosimilars work-sharing
The Access consortium Biosimilars work-sharing initiative is actively exploring opportunities for work-sharing with industry and is seeking applications for this initiative. Applicants who are interested in taking part in this initiative should:
- Download and complete the Expression of Interest (EOI) form below to signal interest in participating in a work sharing submission.
- Submit your completed EOI form to at least two of the Access Consortium members listed below via email. Submit separate applications to each participating regulator within a two-week window of each other.
Please include ‘Access Consortium - Biosimilars work-sharing’ in the subject line of your email.
- Australia: PMABinternationalevaluations@health.gov.au
- Canada: hc.collaboration.sc@canada.ca
- Singapore: HSA_TP_Enquiry@hsa.gov.sg
- Switzerland: Networking@swissmedic.ch
- United Kingdom: access-mhra@mhra.gov.uk
If possible, sponsors should provide the EOI form up to 6 months in advance, particularly when seeking a technical pre-submission meeting. Industry is invited to submit an EOI form at least 3 months before the intended filing date.
Advance Notice: Early interactions with regulators are important for assessing whether work-sharing is a feasible option, and for assisting with alignment and planning discussions.
Consistency in Submission of Information Provided: The content of submissions across partner regulators should be consistent, with the exception of select country-specific application requirements that should be noted in the EOI form.