Global law firm Goodwin today announced the release of the 2025-2026 annual update to its definitive biosimilars treatise Guide to Biosimilars Litigation and Regulation in the U.S. First launched in 2019, the Guide is the industry’s first and leading compendium of the laws and regulations governing biosimilars in the United States and is authored by a multidisciplinary team of experts drawn from Goodwin’s Intellectual Property, Life Sciences, FDA, Antitrust + Competition, and Appellate Litigation practices.
With more than 230 dedicated life sciences lawyers across all major sector hubs in the US, Europe, and Asia, Goodwin works with life sciences companies throughout the corporate life cycle — from startup to maturity — as well as investors, banks, and others in the life sciences ecosystem.
The firm’s Biosimilars Guide takes a deep dive into each section of the Biologics Price Competition and Innovation Act (BPCIA) and examines how the provisions of the statute and related regulations work in practice — at the FDA, in the courtroom, and before the U.S. Patent & Trademark Office (USPTO). It also provides an overview of the latest legal and regulatory issues unique to biosimilar products.
“There were more than 20 new biosimilar products approved by the FDA in 2025, making this a banner year for the still relatively young biosimilars ecosystem,” said Kevin DeJong, Counsel at Goodwin and senior editor of the Guide. “There were also critical new guidance documents issued by the FDA, including major updates to simplify biosimilarity studies and potentially reduce clinical testing for biosimilars. Our Guide provides timely updates on all these recent developments.”
“This year’s update includes a new chapter to the Guide, focusing on prosecution of biologics-related patents, including scope of protection to pursue and discussion of the novelty, obviousness, and Section 112 issues that may arise in seeking protection for biologics-related patents,” said DeJong.
The publication continues to serve as a leading resource for those seeking guidance on topics such as:
- 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
- Regulations and frequently evolving FDA guidance applicable to applications to market biosimilar products
The Goodwin authors include Kevin DeJong as the Senior Editor and Beth Ashbridge, Elaine Herrmann Blais, Jacqueline Genovese Bova, James Breen, Brian Burgess, Linnea Cipriano, Natasha Daughtrey, Brian Drummond, Christopher Holding, Zachariah Holmes, Eric Levi, William Jay, Alexandra Lu, Elizabeth Mulkey, Allegra Padula, Christine Potkay, Emily Rapalino, Alexandra Russell, Michael Siekman, Alison Siedor, Julie Tibbets, Daryl Wiesen, Josh Weinger, Riley Wyberg, Alexandra Valenti, and Huiya Wu as contributors.
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