CHMP Recommends Approval Of Alvotech’s Denosumab Biosimilar AVT03 Commercialised By STADA Arzneimittel AG And Dr Reddy’s Laboratories

Alvotech announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval for AVT03, the company’s proposed biosimilar to Prolia® (denosumab 60 mg/mL pre-filled syringe) and Xgeva® (denosumab 70 mg/mL vial).

If approved, AVT03 will be commercialised in Europe, Switzerland, and the UK by Alvotech’s partners STADA Arzneimittel AG and Dr Reddy’s Laboratories SA, each holding semi-exclusive commercialisation rights. 

“We look forward to working with our partners in making denosumab available more widely to patients and caregivers. This important step demonstrates how Alvotech's specialisation in biosimilars development and manufacture and integrated end-to-end platform enables broader access to affordable biologic medicines,” said Joseph McClellan, Chief Scientific and Technical Officer of Alvotech.

Prolia® is prescribed for the treatment of osteoporosis in postmenopausal women and men at elevated risk of fractures, as well as bone loss in men receiving prostate cancer treatment and in adults on long-term corticosteroid therapy. Xgeva® is used to prevent skeletal complications in patients with advanced cancers that have spread to bone and to treat giant cell tumor of bone in adults and skeletally mature adolescents.

AVT03 remains under EMA review, with a final decision by the European Commission pending. Once approved, STADA will market the biosimilar as Kefdensis® (denosumab 60 mg/mL) and Zvogra® (denosumab 70 mg/mL), while Dr. Reddy’s will use the brand names Acvybra® (denosumab 60 mg/mL) and Xbonzy® (denosumab 70 mg/mL).