Blog Big Molecule Watch November 10, 2021

Amgen and Pfizer Developing More Interchangeable Biosimilars

In their respective third quarter financial results, Amgen and Pfizer both announced plans to seek interchangeable status for select biosimilars.  Amgen announced that patients are currently being enrolled in Phase 3 studies to support interchangeability designation in the U.S. for biosimilars of AMJEVITA (adalimumab) and ABP 654 (ustekinumab).  Pfizer also announced plans to seek interchangeable status for its adalimumab biosimilar ABRILADA in December 2021.  Pfizer also intends to launch a citrate-free biosimilar ABRILADA in the U.S. in July 2023.

There are currently two interchangeable biosimilars that have been approved by the FDA, Pfizer’s SEMGLEE (insulin glargine-yfgn), approved in July 2021, and BI’s CYLTEZO (adalimumab-adbm), approved in October 2021.

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