Press Release November 15, 2019

Goodwin Releases Comprehensive Guide to Biosimilars Litigation and Regulation in the U.S.

New publication is a go-to reference on all things biosimilars

Goodwin today announced the release of its Guide to Biosimilars Litigation and Regulation in the U.S., 2019-2020 ed., a comprehensive reference guide authored by a group of lawyers from Goodwin’s Intellectual Property, Life Sciences, FDA, Products Litigation + Counseling, Antitrust + Competition and Appellate Litigation practices and published by Thomson Reuters.

Since the Biologics Price Competition and Innovation Act (BPCIA) was signed into law as part of the Affordable Care Act in 2010, the Food and Drug Administration has approved more than 20 biosimilar products. As the number of biosimilar approvals has grown, so too has the number of complex and unsettled litigation and regulatory issues.

The Guide to Biosimilars Litigation and Regulation in the U.S. takes a deep dive into each section of the BPCIA and examines how the provisions of the statute and related regulations work in practice — both in at the FDA and in the courtroom. The guide also provides an overview of legal and regulatory issues unique to biosimilars that have arisen or are expected to arise in litigation concerning biosimilar products. Trending topics covered in the guide include:

  • The “patent dance” pre-litigation mechanism for exchanging patent information and contentions
  • Issues of patent infringement, validity, and enforceability, and how they have been litigated in the biosimilars context
  • Antitrust claims regarding tactics used to allegedly halt or delay biosimilar competition
  • Potential product liability issues related to biosimilar products
  • Regulations and frequently-evolving FDA guidance applicable to biosimilar applications

The Goodwin authors include Rob Cerwinski, Michael Cottler and Alexandra Valenti as senior editors, and contributors Christine Armellino, Beth Ashbridge, Naomi Birbach, Elaine Herrmann Blais, Jacqueline Genovese Bova, James Breen, Brian Burgess, Cindy Chang, Linnea Cipriano, Jane Cullis, Natasha Daughtrey, Kevin DeJong, Brian Drummond, Sarah Frederick, Christopher Holding, Zachariah Holmes, Nilda Isidro, William James, William Jay, Glenn Kerner, Ira Levy, Alexandra Lu, Daniel Margolis, Nicholas Mitrokostas, Elizabeth Mulkey, Khurram Naik, Emily Rapalino, Alison Siedor, Steven Tjoe, Josh Weinger, Joshua Whitehill, Daryl Wiesen, Huiya Wu and Keith Zullow.

Goodwin is pleased to offer clients and friends a 10% discount on the purchase of the guide. Use code 10BIOSIM (valid through 12/31/19). To purchase from Thomson Reuters, click here.

To keep up-to-date on legal developments in the biosimilars space, subscribe to our award-winning blog, Big Molecule Watch, or our companion blog, Big Molecule Watch China.