Biosimilar AVT03 Approved: A Key Analysis
The European Commission has officially approved AVT03, a similar version of two important medicines called Prolia and Xgeva. These drugs help treat bone loss and prevent complications in people with serious illnesses like cancer and osteoporosis. This approval opens the door for more affordable treatment options.
Key Points
- AVT03 is a biosimilar, similar to Prolia and Xgeva.
- It treats bone loss in osteoporosis and cancer patients.
- EC approval allows use across all EU and EEA nations.
- Alvotech handles manufacturing, Dr. Reddy’s handles distribution globally.
- Acvybra and Xbonzy are trade names for the biosimilars.
- Focuses on cost-effective medicine for severe health conditions.
Prolia is used to strengthen bones in women after menopause and men at high risk of fractures. It’s also used in men with prostate cancer who are losing bone mass due to hormone treatment. Xgeva prevents bone problems in people with advanced cancers that affect bones and treats giant cell tumors of bone, particularly in young people.
The European Commission’s decision followed a positive assessment by the Committee for Medicinal Products for Human Use (CHMP) in September 2023. This was based on a thorough review of all available data, including how AVT03 compares to the original medicines, how it works in the body, and results from a special study to prove it’s effective.
This approval is valid in every country within the European Union and the European Economic Area, which includes Iceland, Liechtenstein, and Norway. Dr. Reddy’s partnered with Alvotech to get this done – Alvotech will make the drug, and Dr. Reddy’s will handle getting it to patients in the U.S. and Europe.
Dr. Reddy’s has exclusive rights to sell AVT03 in the United States, and a share of the market in Europe and the UK. The biosimilar will be available under the names Acvybra (60 mg/mL solution for injection in a pre-filled syringe) and Xbonzy (70 mg/mL solution for injection in a vial).
“This approval represents a significant step towards providing patients with a high-quality, affordable biosimilar option for treating bone health and cancer-related complications.”
