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Regulatory Focus™ > News Articles > The US Approval Pathway for Biosimilar Products

The US Approval Pathway for Biosimilar Products

Posted 01 October 2010

As part of the recently passed healthcare reform legislation, the US Congress finally amended the Public Health Service Act to allow approval of biosimilars in the US. President Obama signed the Patient Protection and Affordable Care Act into law on 22 March 2010. The law incorporates a specific subsection dealing with biosimilars entitled the Biologics Price Competition and Innovation Act of 2009 (BPCIA). Consistent with the terminology used elsewhere in the world, the legislation uses "biosimilars" when referring to these biopharmaceutical products instead of "follow-on biologics" or some other term, helping to avoid further confusion in this arena.


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