Amneal Pharmaceuticals Files Biologics License Application for Xolair Biosimilar

MT Newswires Live

09/26

Amneal Pharmaceuticals (AMRX) said Friday it submitted a biologics license application for a proposed biosimilar to Kashiv BioSciences-developed Xolair, a registered trademark of Novartis (NVS), with the US Food and Drug Administration.

Omalizumab, the generic name of Xolair, is indicated for the treatment of moderate to severe persistent asthma, chronic rhinosinusitis with nasal polyps, food allergies, and chronic spontaneous urticaria for a range of patient ages, Amneal said.

Amneal said it expects to incur a $22.5 million research and development milestone charge in Q3 rather than Q4. The company said it holds exclusive US commercialization rights for the product.

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