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

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Product details:

Format: Book - softbound
Brand: Thomson West
Copyright: 2021
ISBN: 9781731920386
Service #: 42658211
Sub #: 42658210
Pages: 830
Shelf Space: 2 in.
Publication Frequency: Updated as changes in the law dictate
Update format: No updating

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

106740956

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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)