News

The Biologics Price Competition and Innovation Act (BPCIA) provides an abbreviated pathway for companies to bring biologic drugs to market that are “biosimilar” to previously approved branded reference products by relying on clinical studies that were performed by the reference product sponsor (RPS).

This note introduces biosimilars, the litigation process set up by the BPCIA to facilitate resolution of patent disputes between reference product sponsors and biosimilar manufacturers, and touches on related trends, such as the potential use of inter partes review proceedings by biosimilar manufacturers as an alternative or in addition to litigation.

Whitney Meier has experience litigating biochemistry, biotechnology, and pharmaceutical formulation patents. Whitney was awarded a B.S. degree in Biochemistry with high distinction.

Methodology

Information contained in the Venable Fitzpatrick BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website (www.fda.gov). Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website (www.fda.gov). Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable Fitzpatrick BiologicsHQ database.

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