Amneal Pharmaceuticals Files Biologics License Application for Xolair Biosimilar
MT Newswires Live
Sep 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.
Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.