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FDA Approves First Biosimilars of 2020

As previously reported, the FDA had yet to approve any biosimilars in 2020 as of June 9, despite a growing pipeline. Since then, the FDA has approved two biosimilar products.

On June 11, Pfizer Inc. announced the FDA’s approval of Nyvepria™ (pegfilgrastim-apgf), a biosimilar of Amgen’s Neulasta™. Nyvepria is indicated “to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.” Pfizer’s news release can be found here. This marks the first approval of a biosimilar in 2020.

Mylan N.V. and Biocon Ltd. also announced on June 11, the approval of Semglee™ (insulin glargine injection) for vial and pre-filled pen presentations to control high blood sugar in adults with type 1 and type 2 diabetes and in adolescents with type 1 diabetes. Semglee is a biosimilar to Sanofi’s Lantus® and is approved for the same indications. Mylan’s news release can be found here.