11 months ago
Dr. Reddy's Biosimilar Receives Positive EMA Recommendation
Imagine medicines that are copies of other medicines, but are safe and effective.
These are called biosimilars.
The European Medicines Agency (EMA) has approved AVT03, a biosimilar, for sale in Europe.
AVT03 is similar to two medicines: Prolia and Xgeva.
These medicines help treat osteoporosis (weak bones) and bone problems in cancer patients.
Dr. Reddy’s and Alvotech are working together; Alvotech will make the medicine, and Dr. Reddy’s will sell it.
Dr. Reddy’s will sell the medicine under the names Acvybra and Xbonzy.
This means more people in Europe may have access to medicines that treat bone-related problems.
EMA panel recommended AVT03, a biosimilar, for marketing authorization.
AVT03 is a biosimilar of Prolia and Xgeva (denosumab).
The European Commission will review the recommendation for EEA approval.
Dr. Reddy's has exclusive U.S. rights and semi-exclusive rights in Europe and the UK.
Dr. Reddy’s and Alvotech have a commercialization agreement for AVT03.
- Who
- Dr. Reddy’s and Alvotech
- What
- EMA panel recommended AVT03, a biosimilar for marketing authorization.
- Where
- European Economic Area (EEA) including EU, Norway, Iceland, and Liechtenstein.
- When
- September 2025
- Why
- To provide biosimilar alternatives to treat osteoporosis, bone loss, and bone complications in cancer patients.
Key facts
- Biosimilar Name
- AVT03
- Originator Drugs
- Prolia, Xgeva (denosumab)
- Regulatory Body
- European Medicines Agency (EMA)
- Target Market
- European Economic Area (EEA)
- Commercialization Agreement
- Dr. Reddy's and Alvotech
- Dr. Reddy's Rights
- Exclusive in U.S., semi-exclusive in Europe/UK
Sources
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