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Guide to Biosimilars Litigation and Regulation in the U.S., 2020-2021 ed.

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Brand: Thomson West
Copyright: 2020
ISBN: 9781731964908
Publication Frequency: Updated as changes in the law dictate
Update format: N/A

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THOMSON REUTERS PROVIEW eBOOK EDITION

Guide to Biosimilars Litigation and Regulation in the U.S., 2020-2021 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
  • Summarizes Biosimilars Price Competition and Innovation Act (BPCIA)
  • Analyzes current case law
  • Gives practitioner guidance
  • Includes applicable statutes and regulations
  • Highlights areas for consideration during the FDA approval process
  • Analyzes current case law
  • Includes applicable statutes and regulations
  • Summarizes Biosimilars Price Competition and Innovation Act (BPCIA)
  • Highlights areas for consideration during the FDA approval process
  • Gives practitioner guidance
  • Provides relevant FDA guidance