Dr Reddy's gets EU nod for drug used to treat bone-weakening conditions

The European Commission's approval allows Dr Reddy's to market AVT03 across the European Union and European Economic Area for treating conditions that cause bone weakening

Pharma major Dr Reddy’s Laboratories on Monday said the European Commission (EC) has granted it marketing authorisation for AVT03, a biosimilar to Prolia and Xgeva (denosumab), medicines used to treat bone-related conditions.

 

Prolia is prescribed for osteoporosis in postmenopausal women and men at increased fracture risk, as well as bone loss linked to hormone ablation in men with prostate cancer and long-term glucocorticoid therapy. Meanwhile, Xgeva is used to prevent bone complications in adults with advanced cancers involving bone and to treat adults and skeletally mature adolescents with giant cell tumour of bone, the company said in an exchange filing.

 

It added that the authorisation applies across all European Union (EU) member states and the European Economic Area (EEA) countries: Iceland, Liechtenstein and Norway.

 

"The EC decision follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) adopted in September 2025 and was based on a totality of evidence, including analytical comparisons, pharmacokinetic and pharmacodynamic data, and outcomes from a confirmatory clinical trial," Hyderabad-based pharma major said. 

 

The authorisation follows a licence and supply agreement between Dr Reddy’s and Iceland-based biotech firm Alvotech in May 2024 for the development and commercialisation of AVT03. Under the pact, Alvotech will develop and manufacture the product, while Dr Reddy’s will handle registration and marketing in selected regions, including the US and Europe. The company has exclusive rights in the US, and semi-exclusive rights in Europe and the UK, it said.

 

"Upon approval, Dr Reddy’s will offer the biosimilar under the tradenames 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," it added.

 

Dr Reddy's Q2 performance

 

Dr Reddy’s Laboratories reported a consolidated net profit of ₹1,437.2 crore for the second quarter of the financial year 2025–26 (Q2FY26), a 14 per cent rise from ₹1,255.3 crore in the same period of the previous financial year.

 

Revenue from operations came in at ₹8,805.1 crore, up 9.8 per cent from ₹8,016.2 crore in Q2FY25. Notably, the company’s revenue in Europe increased sharply, rising 138 per cent to ₹1,376 crore.