Shares of Dr Reddy’s Laboratories Ltd were trading 2% higher on 25 November after the company announced that the European Commission (EC) has approved AVT03, a biosimilar version of Prolia and Xgeva, two extensively used drugs for treating osteoporosis and preventing bone-related problems in cancer patients.

The authorisation applies to all 27 EU member states, as well as Iceland, Liechtenstein, and Norway.

Prolia is often used to strengthen bones and minimize fracture risk in postmenopausal women and older men with osteoporosis. It is also used to treat persons who have weakened bones as a result of long-term steroid use or hormone therapy for prostate cancer.

Xgeva, on the other hand, aids in the prevention of major bone problems in individuals whose cancer has migrated to the bone. It is also used to treat a rare tumor known as a giant cell tumour of bone.

The EC’s clearance comes after a positive judgment from the European Medicines Agency’s scientific committee earlier this year. Regulators examined data comparing AVT03 to the original medications, which included studies on how the body absorbs and responds to the treatment, as well as a confirmatory clinical trial.

Alvotech developed and manufactures AVT03 through a licensing agreement signed in 2024.  Dr Reddy’s will commercialise the product, with exclusive rights in the United States and semi-exclusive rights in Europe and the UK. The biosimilar will be marketed in Europe under the trade names Acvybra (for osteoporosis) and Xbonzy (for cancer-related applications).

At 12:20 pm, the shares of Dr Reddy’s Lab were trading 1.75% higher at Rs 1,247.70 on NSE. 

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