AMRX - Amneal Pharmaceuticals gets second U.S. biosimilar approval with FDA nod for Alymsys

Amneal Pharmaceuticals (NYSE:AMRX) on Wednesday announced U.S. Food and Drug Administration (FDA) approval for the company's biologics license application for bevacizumab-maly, a biosimilar of Swiss drugmaker Roche Holding's cancer drug Avastin. The company said the biosimilar will be marketed under the name Alymsys. Alymsys was developed in collaboration with biotech company mAbxience. The FDA's nod marks the second of three biosimilar approvals Amneal expects to get this year in oncology. In March, the FDA approved Amneal's Releukotm, a biosimilar of Amgen's (AMGN) Neupogen, for the treatment of neutropenia. The company's biosimilar referencing Amgen's Neulasta is currently under review by the FDA. AMRX stock +1.8% to $4.42 in aftermarket trading. It had earlier closed 1.2% higher before the announcement.

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Amneal Pharmaceuticals gets second U.S. biosimilar approval with FDA nod for Alymsys