European regulator recommends Alvotech's denosumab biosimilar

The European Medicines Agency's Committee for Medicinal Products for Human Use recommended approval for AVT03, Alvotech's (NASDAQ: ALVO) proposed biosimilar to Prolia and Xgeva, according to a company statement.

The biosimilar targets denosumab, with AVT03 formulated as both a 60 mg/mL pre-filled syringe version and a 70 mg/mL vial version. Prolia treats osteoporosis in postmenopausal women and men at increased fracture risk, while Xgeva prevents bone complications in adults with advanced cancer that has spread to bone.

Upon final approval by the European Commission, STADA Arzneimittel AG will market the biosimilar under the brand names Kefdensis for the 60 mg/mL formulation and Zvogra for the 70 mg/mL version. Dr. Reddy's Laboratories SA will offer corresponding products named Acvybra and Xbonzy. Both partners hold semi-exclusive commercial rights in Europe, including Switzerland and the UK.

"This important step demonstrates how Alvotech specialization in biosimilars development and manufacture and integrated end-to-end platform enables broader access to affordable biologic medicines," said Joseph McClellan, Alvotech's Chief Scientific and Technical Officer.

AVT03 functions as a human monoclonal antibody that targets and binds to the RANK ligand membrane protein, reducing osteoclast numbers and function to decrease bone resorption and cancer-induced bone destruction.

The biosimilar remains under EMA regulatory review pending a final decision by the European Commission.

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