Press Release January 12, 2015

Goodwin Procter Publishes Guidebook On Biosimilars Regulatory, IP Issues

Goodwin Procter announced today the release of Biosimilars: A Guide to Regulatory and Intellectual Property Issues, which examines regulatory approval pathways and intellectual property issues for biologic drug products. In-house attorneys and executives can view the table of contents of Biosimilars: A Guide to Regulatory and Intellectual Property Issues and request a gratis copy of the guide online.

Biosimilars, and other follow-on biologic drug products such as “biobetters,” represent a rapidly expanding segment of the global market for pharmaceuticals. The unique properties of biologics, in particular their differences from traditional “small molecule” drug products, present challenges to current legal and regulatory schemes in the U.S. and abroad. The Guide helps bring clarity to the complex, developing regulatory and legal framework around these drug products.

“As the FDA and other regulatory agencies grapple with the complexities of biosimilars, the legal landscape is changing,” said Elaine Blais, partner in Goodwin Procter’s Intellectual Property Litigation Practice who has lobbied extensively on issues relating to biosimilars. “This Guide will provide the latest analysis and insight, helping in-house attorneys strategize around biosimilars products.”

“A great deal of hyperbole has been published in the last five years about the potential of biosimilars to transform the pharmaceutical industry,” said Goodwin partner Robert Cerwinski, a lead author of the Guide. “Now that the first biosimilar applications have been filed in the U.S., and a number of biosimilars have been approved in highly-regulated markets such as the EU and Japan, there is renewed excitement that this promise is becoming reality. Many significant branded and generic players in the drug industry have moved from thinking about biosimilars to executing on their product development, approval and marketing plans.”

The Guide explores:

  • Market developments for biosimilars
  • Approval pathways for biosimilars in the U.S. and abroad
  • Impact of case law and a review of pending legislation

Biosimilars: A Guide to Regulatory and Intellectual Property Issues is the third in a series of Guidebooks published by Goodwin Procter’s Intellectual Property Litigation Practice.

Goodwin’s Intellectual Property Litigation Practice, recently named by Law360 as one of its “Practice Groups of the Year,” has worked with clients to secure preliminary injunctions, declaratory and summary judgments, favorable results in Markman proceedings, advantageous settlements, victories at trial and appellate relief. Goodwin attorneys routinely work with clients to take cases from pre-suit investigations through discovery and trials. Widely recognized as a leader in life sciences patent matters, Goodwin Procter has been named for three consecutive years as “Biotechnology Law Firm of the Year” by U.S. News Best Lawyers.