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Posted 01 December 2010

Regulatory Update

The US Food and Drug Administration (FDA) held a two-day part 15 public hearing on 2-3 November to discuss with stakeholders an abbreviated approval pathway for biosimilars and interchangeable biological products. The hearing was in response to the Biologics Price Competition and Innovation Act of 2009 (BPCI). The hearing provided input about biosimilars from public health organizations, academia and all parts of the biopharmaceutical industry.

 

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