Forecasting Forthcoming ‘Biosimilar’ Drug Regulations


Traditional pharmaceuticals (small molecule drugs) have long been subject to widespread generic competition under the generic competition provisions of the Drug Price Competition and Patent Term Restoration Act, aka Hatch-Waxman Act. By contrast, biologics, referred to here as “biosimilars,” are large molecule drugs typically made by recombinant DNA techniques, and have not been subject to such widespread generic competition.

To improve access to more affordable therapeutic biologics, such as monoclonal antibodies, vaccines and genetically engineered recombinant proteins, Congress passed the Biologics Price Competition and Innovation Act (BPCIA) of 2009, an amendment to §351 of the Public Health Service Act (PHSA). This created a framework for the U.S. Food and Drug Administration to approve, through an abbreviated approval process, biological products that are “biosimilar” to or “interchangeable” with an already approved product.

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