U.S. Supreme Court To Hear Amgen v. Sandoz Biosimilar Case

The U.S. Supreme Court will hear a closely watched biosimilars court case that will determine whether the 180-day marketing notification in the biosimilar pathway is only effective after FDA licensure, and whether an applicant is required to provide the reference product sponsor its application and related manufacturing information. The court agreed Friday (Jan. 13) to hear Amgen v. Sandoz and Amgen's cross petition. The high court also agreed to allow Apotex, which had a biosimilar petition denied in December...