The U.S. Supreme Court denied a petition from Novartis AG’s Sandoz unit to review the 2020 Federal Circuit decision to uphold two patents of Amgen Inc.’s Enbrel (etanercept). The FDA approved Sandoz’s Enbrel biosimilar, which is known as Erelzi (etanercept-szzs), on Aug. 30, 2016, but the Supreme Court’s decision means Enbrel biosimilars will not be able to launch until 2029. The FDA approved another Enbrel biosimilar, Samsung Bioepis Co., Ltd.’s Eticovo (etanercept-ykro), on April 25, 2019. Novartis says that estimates indicate that a biosimilar of Enbrel could save the U.S. health care system around $1 billion per year.

Viatris Inc. expects the FDA to approve two of its insulin products as interchangeable biosimilars this summer, the company said during its May 10 conference call to report first-quarter 2021 earnings. The company — formed in 2020 through the combination of Mylan N.V. and Pfizer’s Upjohn business — said its insulin glargine, whose reference drug is Sanofi’s Toujeo, and insulin aspart, whose reference drug is Novo Nordisk’s NovoLog/NovoRapid, are on track to be approved as interchangeable in July. As of early June, the FDA has approved 29 biosimilars, but none have the interchangeable designation. Insulins became eligible for biosimilar status when the FDA transitioned certain protein products approved under the Federal Food, Drug, and Cosmetic Act to the Public Health Service Act on March 23, 2020.

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