New Work Sharing Initiative from the Access Consortium for assessment of Biosimilar applications

Biosimilar Working Group (BSWG)


The Access Consortium is a collaborative initiative of like-minded, medium-sized regulatory authorities between Australia's Therapeutic Goods Administration (TGA), Health Canada (HC), Singapore's Health Sciences Authority (HSA), the Swiss Agency for Therapeutic Products (Swissmedic) of Switzerland and the Medicines and Healthcare products Regulatory Authority (MHRA) of the United Kingdom.

The New Active Substance Work Sharing Initiative (NASWSI) has successfully approved several medicines through this international collaboration and continues to foster cooperation and strong relationships between its Access partners. The Biosimilar Medicine Work Sharing Initiative (BSWSI) builds on this success. A work sharing pilot project is available for companies that submit an authorisation application for a biosimilar in at least two members of the Access Consortium. The relevant information can be found here: