High Court Interprets The Biosimilars Statute — What Now?
On Monday, the U.S. Supreme Court issued its first interpretation of the biosimilars statute, the Biologics Price Competition and Innovation Act of 2009. The BPCIA, part of Obamacare, introduced an abbreviated pathway for regulatory approval of biosimilars, allowing biosimilars to piggyback on the regulatory data of innovator biologics for their approval. Biosimilars are biologic medicines, grown in living cells, that copy innovator biologics but, due to the complexity of biologic medicines, cannot precisely duplicate them. Along with the regulatory pathway, the BPCIA provides carefully calibrated patent dispute resolution procedures to allow innovator companies to protect their patent rights. The ruling addresses these patent dispute resolution procedures in the first patent action under the BPCIA, Amgen Inc. v. Sandoz Inc., and involves the first U.S. biosimilar product, Sandoz’s Zarxio.
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