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BPCIA: Patent Dance Steps Becoming a Bit Clearer

Amgen v. Hospira (Fed. Cir. 2017) The dispute here falls under the Biologics Price Competition and Innovation Act of 2009 (BPCIA), which can be loosely described the Hatch-Waxman equivalent for large-molecule biologics. Particularly, BPCIA creates an abbreviated approval pathway for products that are “biosimilar” to an already FDA-approved biological drug product.  Unfortunately, the
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