Dr. Reddy's Receives EC Approval for AVT03, Biosimilar of Prolia® and Xgeva®
Dr. Reddy's Laboratories receives European Commission approval for AVT03, a biosimilar of Prolia® and Xgeva®. This follows a partnership with Alvotech for development and commercialization.
The approval expands Dr. Reddy's product portfolio and market reach, particularly in the biosimilars sector. It also strengthens the company's partnership with Alvotech. While significant, the impact is considered medium as the financial details are not disclosed.
The announcement indicates a positive regulatory outcome with the European Commission's approval, which will allow Dr. Reddy's to commercialize its biosimilar product in Europe.
* Dr. Reddy’s Laboratories announced that the European Commission (EC) has granted marketing authorization for AVT03, a biosimilar of Prolia® (denosumab) and Xgeva® (denosumab). * The EC decision follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) adopted in September 2025. * In May 2024, Dr. Reddy’s and Alvotech entered into a license and supply agreement for the commercialization of AVT03. Alvotech will develop and manufacture AVT03, while Dr. Reddy’s is responsible for registration and commercialization in applicable markets, including the U.S. and Europe. * Dr. Reddy’s will offer the biosimilar under the tradenames Acvybra® (denosumab) 60 mg/mL solution for injection in a pre-filled syringe and Xbonzy® (denosumab) 70 mg/mL solution for injection in a vial.
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Dr. Reddy's Laboratories Limited filed this with the NSE as a statutory disclosure, categorised under product launches. It is a primary document, not a recommendation, and the desk marks it medium impact: worth reading, rarely worth acting on by itself.
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