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3 December 2015AmericasGerard Norton and Michael Montgomery

To dance or not to dance: biosimilar strategies post Amgen v Sandoz

The Biologics Price Competition and Innovation Act (BPCIA) is a landmark piece of legislation signed into law by the Obama administration in 2009. The BPCIA provides for a regulatory approval pathway for biosimilar products, which are like generic pharmaceuticals in that they are based on already approved ‘name brand’ biologics.

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More on this story

Americas
US approves second biosimilar drug
6 April 2016   The US Food and Drug Administration has approved a biosimilar version of Janssen Biotech’s drug Remicade.
Americas
Apotex ordered to provide 180 days’ biosimilar notice to Amgen
15 December 2015   Parties are required to provide 180 days’ notice to a patent owner before marketing a biosimilar version of its drug, a US district court has ruled.


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