Dr Reddy’s gets EU approval for osteoporosis drug AVT03, a biosimilar to Prolia and Xgeva

Dr Reddy’s Laboratories has received approval from the European Commission (EC) for AVT03, a biosimilar version of Prolia and Xgeva—widely used medicines for treating osteoporosis and preventing bone-related complications in cancer patients.

The authorisation covers all 27 EU nations, along with Iceland, Liechtenstein and Norway.

Prolia is commonly prescribed to strengthen bones and reduce fracture risk in post-menopausal women and older men with osteoporosis. It is also used for people whose bones weaken

due to long-term steroid use or hormone therapy for prostate cancer.

Xgeva, on the other hand, helps prevent serious bone problems in patients whose cancer has spread to the bone and is also used to treat a rare tumour called giant cell tumour of bone.

The EC’s approval follows a positive opinion from the European Medicines Agency’s scientific committee earlier this year. Regulators reviewed data comparing AVT03 with the original drugs, including studies on how the body absorbs and responds to the treatment, as well as a confirmatory clinical trial.

AVT03 is developed and manufactured by Alvotech under a licensing partnership signed in 2024. Dr Reddy’s will commercialise the product and holds exclusive rights for the US and semi-exclusive rights in Europe and the UK. The biosimilar will be sold in Europe under the brand names Acvybra (for osteoporosis) and Xbonzy (for cancer-related uses).

Ahead of the announcement, shares of Dr Reddy’s closed 1.6% lower at ₹1,224 on the NSE.