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FDA Approves AVSOLA (infliximab-axxq), a Biosimilar to Remicade®

Amgen continues to grow its portfolio of biosimilar medications with the recent approval of AVSOLA (infliximab-axxq) by the U.S. Food and Drug Administration (FDA) on Dec. 6, 2019. Biosimilars are medications that are biologically similar to existing biologic treatments, offering patients more affordable medication options. AVSOLA was approved for all indications of chronic inflammatory conditions as the reference product, Remicade® (infliximab).

The approval marks an important milestone for Amgen’s portfolios of both biosimilar and inflammation medicines, as AVSOLA becomes the fourth biosimilar from Amgen’s portfolio to receive FDA approval, and Amgen’s second biosimilar to receive FDA approval for chronic inflammatory conditions.

This milestone supports Amgen’s continued commitment to providing high-quality biosimilars that offer patients more affordable, life-altering biological treatment options. The availability of biosimilars like AVSOLA contributes to the sustainability of the healthcare system, providing additional therapeutic options for patients, while supporting greater investment in new medicines for the future.

Read the press release to learn more.