US Supreme Court Denies Sandoz’s Petition To Review Biosimilar CaseBy
The US Supreme Court has denied Sandoz’s petition to review a lower court’s decision in July 2020 concerning Sandoz’s biosimilar of Enbrel (etanercept), one of Amgen’s top-selling drugs with 2020 global sales of $4.9 billion.
Sandoz received approval from the US Food and Drug Administration for its biosimilar of etanercept in August 2016, but the company has not launched the biosimilar in the US due to ongoing patent litigation.
A federal circuit court previously ruled against Sandoz and upheld Amgen’s patents. Due to the US Supreme Court’s decision to not review the case, Sandoz’s Reelz (etanercept-sizes) will not be available in the US until 2029.