In a significant regulatory achievement, Indian pharmaceutical major Dr Reddy's Laboratories has obtained crucial marketing authorisation from the European Commission for its biosimilar drug AVT03, used in the treatment of osteoporosis and related bone conditions.
Comprehensive European Market Access
The European Commission's approval grants marketing rights across all European Union member states, along with Iceland, Liechtenstein, and Norway under the European Economic Area framework. This broad authorization positions Dr Reddy's to access one of the world's largest pharmaceutical markets with its denosumab biosimilar.
The company confirmed that AVT03 serves as a biosimilar version of two established medications - Prolia and Xgeva. Both reference drugs are widely prescribed for managing bone loss and reducing fracture risk in various patient populations.
Therapeutic Applications and Patient Benefits
According to the company's announcement, Prolia is primarily used for treating osteoporosis in post-menopausal women and men at increased risk of fractures. The medication also addresses bone loss associated with hormone ablation therapy in prostate cancer patients and long-term systemic glucocorticoid use.
Xgeva, the other reference product, is indicated for preventing skeletal complications in adults with advanced cancers that involve bone metastases. The treatment is also approved for skeletally mature adolescents and adults diagnosed with giant-cell bone tumours.
Strategic Partnership and Market Expansion
This regulatory milestone follows a license and supply agreement signed in May 2024 between Dr Reddy's and Alvotech. Under this partnership arrangement, Alvotech will continue to handle development and manufacturing responsibilities for AVT03, while Dr Reddy's will manage registration and commercialisation activities across applicable markets, including Europe and the United States.
The market response to this development saw Dr Reddy's shares closing at Rs 1,224.75 on the Bombay Stock Exchange on Monday, reflecting a 1.59 percent decline from previous trading levels.
This European approval represents a substantial step forward for Dr Reddy's biosimilar portfolio and strengthens the company's position in the global specialty pharmaceuticals market. The authorization enables patients across Europe to access more affordable treatment options for serious bone-related conditions while expanding Dr Reddy's international footprint.
