FDA Approves Accord’s Higher Strength Herceptin Biosimilar

Following the FDA’s approval of A 150mg version of Accord’ Herceptin biosimilar, the US agency has now greenlit a higher 400mg strength version of the rival.

The US Food and Drug Administration has approved Accord BioPharma’s 420mg strength Herceptin (trastuzumab) biosimilar Hercessi as a treatment for HER-2 overexpressing breast and gastric or gastroesophageal junction adenocarcinoma, adding to the past approval of the drug’s 150mg formulation earlier this year.

The approval of the 150mg version of the biosimilar earlier this year in April marked the FDA’s 50th biosimilar approval,...

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