The rules of the biosimilars pathway could change now that the Supreme Court has agreed to hear Amgen Inc. and Sandoz Inc. petitions challenging the Federal Circuit’s interpretation of the statute. At stake is whether biosimilar sponsors must wait 180 days after approval to notify the brand-name company of intent to launch and whether the exchange of patent information is optional.
In orders issued Jan. 13, the court granted both Sandoz’s petition on launch notification and Amgen’s conditional cross-petition on the...
