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  1. Dr. Reddy’s Lab shares rise 2% on receiving European Commission nod for biosimilar to treat osteoporosis

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Dr. Reddy’s Lab shares rise 2% on receiving European Commission nod for biosimilar to treat osteoporosis

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2 min read | Updated on November 25, 2025, 11:18 IST

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SUMMARY

The EC approval will be valid in all European Union (EU) member states as well as in the European Economic Area (EEA) countries of Iceland, Liechtenstein and Norway.

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Dr. Reddy’s shares

In May 2024, Dr. Reddy’s and Alvotech entered into a license and supply agreement for the commercialisation of AVT03. | Image: Shutterstock

Dr. Reddy’s share price: Shares of Dr. Reddy’s Laboratories surged 1.61% to an intra-day high of ₹1,246 apiece on the National Stock Exchange (NSE) on Tuesday, November 25, after it received the European Commission’s approval for the AVT03 (denosumab) drug, a biosimilar of Prolia and Xgeva.
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The stock was trading 0.92% higher at ₹1,237.50 per equity share, as of 11:17 am.

“Prolia is a prescription medicine used to treat osteoporosis in women who have been through menopause and in men who are at increased risk of fractures, bone loss linked to hormone ablation in men with prostate cancer at increased risk of fractures and bone loss associated with long-term treatment with systemic glucocorticoids,” the company said in a regulatory filing dated November 24.

Furthermore, Xgeva is a prescription medicine used to prevent bone complications in adults with advanced cancer involving bone. It is also used for the treatment of adults and skeletally mature adolescents with giant cell tumour of bone.

The EC decision follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) adopted in September 2025, it added.

The EC’s approval is valid in all European Union (EU) member states as well as in the European Economic Area (EEA) countries of Iceland, Liechtenstein and Norway.

In May 2024, Dr. Reddy’s and Alvotech entered into a license and supply agreement for the commercialisation of AVT03, it added.

Under the agreement, Alvotech will develop and manufacture AVT03, while the Indian drugmaker will be responsible for registration and commercialisation in the U.S. and Europe, with the latter having exclusive commercialisation rights in the US and semi-exclusive in Europe and the UK.

Upon approval, Dr. Reddy’s will offer the biosimilar under the tradename Acvybra 60 mg/mL solution for injection in a pre-filled syringe and Xbonzy 70 mg/mL solution for injection in a vial, it stated.

Shares of the Hyderabad-headquartered drugmaker closed 1.60% lower at ₹1,224 apiece on the National Stock Exchange (NSE) on Monday. However, the development was announced after the market closed.

Dr. Reddy's Laboratories has a total market capitalisation of ₹1.03 lakh crore, as of November 25, 2025, according to data on the NSE.

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