Guide to Biosimilars Litigation and Regulation in the U.S., 2021-2022 ed.

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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.

This resource also includes discussion of the 20+ cases making their way through the judicial system.

Related statutes and regulations, agency guidance, and other relevant materials are included in the extensive appendices.

Features

Provides relevant FDA guidance
Gives practitioner guidance
Includes applicable statutes and regulations
Highlights areas for consideration during the FDA approval process
Analyzes current case law
Summarizes Biosimilars Price Competition and Innovation Act (BPCIA)