Available Now. Goodwin’s Guide to Biosimilars Litigation and Regulation in the U.S.

Building on Big Molecule Watch’s knowledge of and presence in the biosimilars space, we are excited to announce that Goodwin has developed a new comprehensive guide and go-to reference for all things biosimilars published by Thomson Reuters. The  Guide to Biosimilars Litigation and Regulation in the U.S. was authored by a group of lawyers at Goodwin, largely comprised of Big Molecule Watch editors, and is now available for purchase. The Guide provides expert guidance and practical know-how for lawyers working in this burgeoning area of the law.

Guide to Biosimilars Litigation and Regulation in the U.S. discusses each section of the BPCIA and how the provisions of the statute and related regulations work in practice. 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.

To purchase the Guide, click here.

For regular updates on legal developments in the biosimilars space, keep reading Big Molecule Watch, or our companion blog, Big Molecule Watch China.


Christine Armellino William M. Jay
Beth Ashbridge Glenn S. Kerner
Naomi Birbach Scott Lassman
Elaine Herrmann Blais Ira J. Levy
Jacqueline Genovese Bova Alexandra Lu
James Breen Daniel Margolis
Brian Burgess Nicholas K. Mitrokostas
Robert V. Cerwinski Elizabeth Mulkey
Cindy Chang Khurram Naik
Linnea P. Cipriano Emily L. Rapalino
Michael B. Cottler Alison Siedor
Jane Cullis Steven S. Tjoe
Natasha E. Daughtrey Vi Tran
Kevin J. DeJong Alexandra D. Valenti
Brian T. Drummond Lindsey A. Wanner
Samantha M. Flener Josh Weinger
Sarah K. Frederick Joshua A. Whitehill
Christopher T. Holding Daryl L. Wiesen
Zachariah Holmes Huiya Wu
Nilda M. Isidro Jenny J. Zhang
William G. James Keith A. Zullow