Skip to Main Content

In a development with widespread implications for health care costs, the US solicitor general recommended that the US Supreme Court review a heated dispute over a rule that will determine when lower-cost biosimilar medicines can be launched. And the solicitor general also took a position that may provide a boost to biosimilar manufacturers.

At issue is the ability of brand-name drug makers to delay the introduction of biosimilars, which are highly identical versions of expensive biologics, but are expected to cost less.


The rule that the Supreme Court will review concerns the notice that a brand-name company is entitled to receive from a drug maker that wants to sell a biosimilar. The rule is found in a federal law known as the Biologics Price Competition and Innovation Act, which says a company seeking to sell a biosimilar must give the manufacturer of the brand-name biologic at least a 180-day notice before selling its drug (see page 10).

Unlock this article by subscribing to STAT+ and enjoy your first 30 days free!