AVT03 Biosimilar Approved: An Analysis

The European Commission has officially given the green light for AVT03, a new medicine that works similarly to Prolia and Xgeva. These medicines are used to strengthen bones and prevent fractures in people who are at risk. This approval is a big step for Dr. Reddy’s Laboratories and their partner, Alvotech, as it means AVT03 can be sold across Europe and the United States.

Key Points

• AVT03 is a biosimilar version of Prolia and Xgeva.
• It helps strengthen bones and prevent fractures in patients.
• EC approval follows positive CHMP opinion in September 2025.
• Alvotech develops, manufactures AVT03 while Dr. Reddy’s handles sales.
• Acvybra and Xbonzy are the brand names for the new drugs.
• Exclusive U.S. rights for Dr. Reddy’s, semi-exclusive in Europe.

Prolia and Xgeva are used to treat osteoporosis, a condition where bones become weak and easily broken. They are used in women who have gone through menopause and in men with certain health conditions. This new biosimilar, AVT03, offers a more affordable option for patients needing these treatments.

The decision was based on careful testing and comparisons with the original medicines. This included studying how the body processes AVT03 and looking at the results of clinical trials. The European Commission’s approval covers all EU countries, plus Iceland, Liechtenstein and Norway.

Dr. Reddy’s Labs has partnered with Alvotech for this project. Alvotech is responsible for making the medicine, while Dr. Reddy’s will handle getting it approved and selling it. The first brand names for the new medicines are Acvybra and Xbonzy, and they will be available in pre-filled syringes and vials.

“This approval unlocks access to a critical medicine for vulnerable populations, driven by rigorous scientific evaluation.”