The US Biosimilars Patent Litigation Outlook For 2019

Law360 (January 18, 2019, 3:49 PM EST) -- In 2010, President Barack Obama signed the Biologics Price Competition and Innovation Act into law as part of the Affordable Care Act, establishing an abbreviated regulatory pathway for biosimilar approvals and a unique litigation framework for resolving biosimilar-related patent disputes. The first biosimilar in the U.S., Sandoz Inc.’s Zarxio (filgrastim-sndz), did not reach the market through this pathway until late 2015. Since then, each year has seen more U.S. Food and Drug Administration approvals than the year before. 2018 was no different, boasting a record seven biosimilar approvals, bringing the total number to 16.

Whereas only one biosimilar launched in each...

Stay ahead of the curve

In the legal profession, information is the key to success. You have to know what’s happening with clients, competitors, practice areas, and industries. Law360 provides the intelligence you need to remain an expert and beat the competition.


  • Access to case data within articles (numbers, filings, courts, nature of suit, and more.)
  • Access to attached documents such as briefs, petitions, complaints, decisions, motions, etc.
  • Create custom alerts for specific article and case topics and so much more!

TRY LAW360 FREE FOR SEVEN DAYS