Supreme Court Rules for Biosimilar Applicants under the BPCIA On June 12, 2017, the Supreme Court released a decision in Sandoz Inc. v. Amgen Inc., which involved a case emerging out of the Biologics Price Competition and Innovation Act. The Biologics Price Competition and Innovation Act of 2009 (BPCIA) provides an abbreviated pathway for biosimilar products of already licensed biological products (reference products) […] Continue Reading →
Federal Circuit Upholds 180-Day Notice Period for Biosimilars On Tuesday, the Federal Circuit sustained an injunction preventing generic drug maker Apotex, Inc. from selling a similar version of Amgen Inc’s Neulasta drug without a 180 day notice period after being approved by the FDA. The drug is used to boost white blood cell counts in cancer patients and is made using living cells. […] Continue Reading →
White House Calls for Modernization of Biotechnology Regulations Biotechnological innovation is potentially subject to a variety of governmental regulations. For example, therapeutics for disease treatment or prevention in humans are subject to review and approval by the Food and Drug Administration (FDA). Innovations relating to crops or livestock may be subject to the Department of Agriculture (USDA). However, the regulations promulgated by these governmental agencies are […] Continue Reading →
Federal Circuit Weighs in on Abbreviated Biosimilar Applications The Biologics Price Competition and Innovation Act (BPCIA) establishes an abbreviated pathway for regulatory approval of follow-on biological products that are highly similar to a previously approved product (the reference product). The general structure of the abbreviated pathway, referred to as “biosimilar” licensure , is similar to that used for Abbreviated New Drug Applications (ANDA) under the […] Continue Reading →
FDA Releases First “Purple Book” for Biosimilar Products The Biosimilars Act (BSA) was passed into law on March 23, 2010 with the goal of encouraging the market entry of generic products, similar to the system that exists for generic drugs under the Hatch-Waxman Act. The BSA sets forth an abbreviated approval pathway for biologics through a regulatory demonstration of biosimilarity (i.e. interchangeability). More […] Continue Reading →