Supreme Court to review key Biosimilar Dispute between drugmakers Amgen and Novartis’ Sandoz unit over the process for launching a biosimilar version of a branded biologic
Reporter: Aviva Lev-Ari, PhD, RN
- The Supreme Court last week agreed to review a dispute between drugmakers Amgen and Novartis’ Sandoz unit over the process for launching a biosimilar version of a branded biologic, setting the stage for an important ruling later this year.
- At issue are key provisions of the Biologics Price Competition and Innovation Act (BPCIA) which govern when a biosimilar developer needs to give notice to branded drugmakers of its intent to sell a biosimilar, which are highly similar, copycat versions of pricey biologic drugs.
- While the legal details are technical, the case will set an important precedent for the emerging field and could clarify how biosimilars are brought to market.
The case also involves whether biosimilar drugmakers are required to disclose a copy of a biosimilar application and information about its manufacturing processes to the branded drugmaker — a process known as the “patent dance.”
see Dive Insight:
Supreme Court to review key biosimilar dispute
Jan. 17, 2017
ANALYSIS OF SOLICITOR GENERAL’S BRIEF IN SANDOZ V. AMGEN