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

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Product details:

Format: Book - softbound
Brand: Thomson West
Copyright: 2020
ISBN: 9781539286738
Service #: 42658211
Sub #: 42658210
Pages: 808
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., 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

  • 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