Alvotech's AVT03 Biosimilar Receives Positive CHMP Opinion for European Approval

Alvotech, a biotech company, has announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for its proposed biosimilar AVT03, which is similar to Prolia and Xgeva. The biosimilar will be marketed by Alvotech's commercial partners STADA and Dr. Reddy's Laboratories in Europe, pending approval. This development aims to make denosumab available more widely to patients and caregivers.

Reykjavik, Iceland, September 12, 2025 (GLOBE NEWSWIRE) — Alvotech (NASDAQ: ALVO), a global biotech company specializing in biosimilar medicines, has received a significant regulatory milestone with the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adopting a positive opinion for its proposed biosimilar AVT03. This decision represents a critical step towards the approval and commercialization of AVT03 in Europe, which is a biosimilar to Prolia® and Xgeva® (denosumab).

The EMA's CHMP recommendation for AVT03, a human monoclonal antibody, signals imminent European market entry for Alvotech. Upon approval, the biosimilar will be marketed by STADA Arzneimittel AG and Dr. Reddy's Laboratories SA, each with semi-exclusive commercial rights in Europe, including Switzerland and the UK. The biosimilar will be available in two formulations: a 60 mg/mL pre-filled syringe and a 70 mg/mL vial, targeting conditions such as osteoporosis in postmenopausal women, bone loss in cancer patients, and giant cell tumor of bone.

The strategic partnership structure with STADA and Dr. Reddy's for semi-exclusive commercial rights creates an efficient market entry pathway for Alvotech without needing to build its own European sales infrastructure. Each partner will market the product under different brand names—STADA using Kefdensis and Zvogra, while Dr. Reddy's will use Acvybra and Xbonzy.

Denosumab biosimilars represent a substantial market opportunity, given the significant patient populations for the reference products. Prolia targets osteoporosis in postmenopausal women and men with fracture risk, while Xgeva addresses bone complications in advanced cancer and giant cell tumor of bone. The original products generate significant revenue, and biosimilar entry typically creates market expansion through improved affordability and access.

This recommendation demonstrates the effectiveness of Alvotech's integrated platform approach to biosimilar development, highlighting their ability to navigate complex regulatory pathways for monoclonal antibodies. The company's focused business model as a pure-play biosimilar developer continues to show validation through regulatory advancement.

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

AVT03 remains under EMA regulatory review with a final decision by the European Commission pending. Upon approval, STADA will offer the biosimilar under the tradenames Kefdensis® (denosumab) 60 mg/mL solution for injection in a pre-filled syringe and Zvogra® (denosumab) 70 mg/mL solution for injection in a vial, while Dr. Reddy's will use 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.

Alvotech's current development pipeline includes nine disclosed biosimilar candidates aimed at treating autoimmune disorders, eye disorders, osteoporosis, respiratory disease, and cancer. The company has formed a network of strategic commercial partnerships to provide global reach and leverage local expertise in markets that include the United States, Europe, Japan, China, and other Asian countries and large parts of South America, Africa, and the Middle East.