On May 21, Alvotech announced that it had entered into a license and supply agreement with Dr. Reddy’s Laboratories SA for the commercialization of AVT03, a proposed denosumab biosimilar.  Denosumab, sold by Amgen under the brand names PROLIA and XGEVA, is indicated for the treatment of various diseases including osteoporosis in postmenopausal women and prevention of skeletal-related events in adults with advanced malignancies.  According to the press release, Alvotech will be responsible for development and manufacturing of the product and Dr. Reddy’s will be responsible for registration and commercialization of the product in the applicable markets.

On May 27, Fresenius Kabi announced that the U.S. Food and Drug Administration (FDA) accepted its Biologics License Application (BLA) for its denosumab biosimilar candidate referencing PROLIA and XGEVA.  Fresenius Kabi’s BLA is the third publicly reported application to FDA for a denosumab biosimilar, following Sandoz and Celltrion.  Sandoz’s denosumab biosimilar was approved by the FDA in March 2024, while Celltrion’s BLA for its denosumab biosimilar remains pending with the FDA.

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