Yesterday, the U.S. Supreme Court heard oral argument in the much-anticipated Amgen v. Sandoz case, representing the first time the Court has had to grapple with the Biologics Price Competition and Innovation Act ("BPCIA") since this key law went into effect in 2010. The BPCIA created a new, abbreviated pathway for highly similar biological products to enter the U.S. market by following in the footsteps of a reference biological product. The Court's decision, which should issue in June, will be closely watched by participants in the pharmaceutical, biotech, and health care sectors.
To read our full alert on the oral argument, please click here.
A written transcript of the oral argument is available here. An oral recording will be made publicly available at the end of this week.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
