Snapshot

The ACCESS Biosimilars Work-Sharing Initiative (BSWSI) pathway has been developed by the of ACCESS Worksharing Program.

This pathway can be used where Biosimilar medicinal products.

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

Regional regulatory initiatives can help optimize the efficient use of an agency’s resources. The following countries participate in this initiative/pathway: Australia Canada Singapore Switzerland United Kingdom

The BSWSI supports the regulatory filing of a new biosimilar regulatory application to at least two or more consortium members. The application and work-sharing process under the BSWSI initiative is identical to the NASWSI. The sponsor may only request a review under the standard pathway, as the priority pathway is only available under the NASWSI. Total maximum elapsed time from acceptance of the application to the start of the national steps: 225-255 calendar days [180 days excluding applicant time/stop-clocks]. The work-sharing process formally concludes at the end of the evaluation phase as the process enters into Phase 3 National Steps. Each agency will progress towards making a final decision (or seeking further clarification on issues separately before making a final decision) by undertaking necessary administrative steps to finalise the application process domestically.