As regular Big Molecule Watch readers know, the Biologics Price Competition and Innovation Act (“BPCIA”) was signed into law as part of the Affordable Care Act on March 23, 2010, creating an abbreviated licensure pathway for “biosimilar” and “interchangeable” biological products. The BPCIA also introduced a new scheme to resolve patent disputes involving biosimilar products known as the “patent dance.” Since the enactment of the BPCIA, the FDA has approved nearly 30 biosimilar products, and, as the market has grown, litigation activity concerning biosimilars has increased rapidly.
We are excited to announce that Goodwin has released a new edition of our guide published by Thomson Reuters, ensuring that this go-to reference for all things biosimilars reflects regulatory and legal developments since the publication of our first edition. The Guide to Biosimilars Litigation and Regulation in the U.S. 2020-2021 Edition provides expert guidance and practical know-how for lawyers working in this burgeoning area of the law.
Guide to Biosimilars Litigation and Regulation in the U.S. discusses each section of the BPCIA and how the provisions of the statute and related regulations work in practice – both in regulatory and litigation settings. The Guide also provides an overview of legal and regulatory issues unique to biosimilars that have arisen or are expected to arise in litigation concerning biosimilar products.