Dr. Reddy's Receives Positive CHMP Opinion for Biosimilar AVT03

Dr. Reddy's Laboratories has received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use for its biosimilar AVT03, which is similar to Prolia and Xgeva. The company plans to submit a Marketing Authorisation Application to the UK Medicines and Healthcare products Regulatory Agency separately. AVT03 will be commercialized by Alvotech, while Dr. Reddy's will handle registration and marketing in applicable markets, including the US and Europe.

Dr. Reddy's Laboratories has received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) for its biosimilar AVT03, which is similar to Prolia and Xgeva. The company plans to submit a Marketing Authorisation Application to the UK Medicines and Healthcare products Regulatory Agency separately. AVT03 will be commercialized by Alvotech, while Dr. Reddy's will handle registration and marketing in applicable markets, including the US and Europe.

The positive opinion from the CHMP for AVT03, a biosimilar to Prolia (denosumab 60 mg/mL single use pre-filled syringe) and Xgeva (denosumab 70 mg/mL single use vial), represents a significant milestone for Alvotech. The biosimilar targets osteoporosis in postmenopausal women, bone loss in cancer patients, and giant cell tumor of bone. Upon approval, AVT03 will be marketed by Alvotech's commercial partners, STADA Arzneimittel AG and Dr. Reddy's Laboratories SA, with semi-exclusive commercial rights in Europe, including Switzerland and the UK. STADA will market the product under the tradenames Kefdensis and Zvogra, while Dr. Reddy's will use Acvybra and Xbonzy.

The strategic partnership structure with STADA and Dr. Reddy's for semi-exclusive commercial rights throughout Europe creates an efficient market entry pathway without Alvotech needing to build its own European sales infrastructure. The positive opinion from the CHMP for Alvotech's denosumab biosimilar signals imminent European market entry, boosting commercial prospects through established partnerships. Denosumab biosimilars represent an important market opportunity as the reference products address conditions with substantial patient populations. The original products generate significant revenue, and biosimilar entry typically creates market expansion through improved affordability and access.

Alvotech's focused business model as a pure-play biosimilar developer continues to show validation through regulatory advancement. The company's integrated platform approach to biosimilar development highlights their ability to navigate complex regulatory pathways for monoclonal antibodies. AVT03 remains under EMA regulatory review with a final decision by the European Commission pending. Upon approval, STADA and Dr. Reddy's will offer the biosimilar under different brand names in Europe.