Description
Guide to Biosimilars Litigation and Regulation in the U.S. is an understandable guide and go-to reference, providing expert and practical guidance for attorneys working in this burgeoning area of the law.; The title explores each section of the Biologics Price Competition and Innovation Act (BPCIA) as well as an overview of legal and regulatory issues unique to biosimilars that have arisen, or are expected to arise, in litigation concerning biosimilar products.; Related statutes and regulations, litigation summaries, agency guidance, and other relevant materials are included in the extensive appendices.
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