Leaders in Pharmaceutical Business Intelligence (LPBI) Group

Dive Brief:

• 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.