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Joint TGA/PBD discussion paper on Similar Biological Medicinal Products (SBMPs)

Consultation

14 July 2010

This consultation closed on 8 September 2010

A Biologics Forum, attended by representatives of the Pharmaceuticals Industry Council (PIC), comprising Medicines Australia, Ausbiotech and the Generic Medicines Industry Association (GMiA), and the Department of Health and Ageing was held in December 2009, to discuss the regulation and reimbursement of biological products in Australia.

In response to this meeting, the Therapeutic Goods Administration (TGA) and the Pharmaceutical Benefits Division (PBD) produced a joint discussion paper regarding the regulation and reimbursement of Similar Biological Medicinal Products (SBMPs).

The TGA/PBD draft discussion paper was released on 14 July 2010 for public consultation, inviting written submissions from all interested stakeholders.