Recent Updates
Recently added Catalysts
RDY Positive Sentiment Score: 75/100

Dr. Reddy's Laboratories Ltd . 8-2-337, Road No. 3, Banjara Hills Hyderabad - 500 034, Telangana, India CIN: L85195TG1984PLC004507 Tel: + 91 40 4900 2900 Fax: + 91 40 4900 2999 Email: mail@drreddys.com Web: www.drreddys.

Key Takeaway: Dr. Reddy's Laboratories has announced that the European Medicines Agency's Committee for Medicinal Products for Human Use has adopted a positive opinion regarding the marketing authorization of AVT03, a proposed biosimilar for Prolia and Xgeva. This decision paves the way for Dr. Reddy's to enter the European market with their biosimilar treatment aimed at conditions like osteoporosis and advanced cancer-related bone issues. The company has a licensing agreement with Alvotech for the development and manufacturing of AVT03, signaling strong collaboration in bringing this product to market.

Market Sentiment Analysis

POSITIVE FACTORS

  • Dr. Reddy's receives a positive opinion from the CHMP for AVT03.
  • The biosimilar targets significant health issues like osteoporosis and bone complications.
  • Exclusive commercialization rights for the U.S. are a strong market position.

Full Press Release Details

National Stock Exchange of India Ltd. (Scrip Code: DRREDDY)
BSE Limited (Scrip Code: 500124)
New York Stock Exchange Inc. (Stock Code: RDY)
NSE IFSC Ltd. (Stock Code: DRREDDY)
Please find enclosed a Press Release viz. "Dr. Reddy's receives positive CHMP opinion from European Medicines Agency for AVT03 (denosumab), a proposed Biosimilar of Prolia and Xgeva "
This is for your information and records.
For Dr. Reddy's Laboratories Limited
Company Secretary, Compliance Officer & Head-CSR
CONTACT
DR. REDDY'S LABORATORIES LTD. Investor relationS Media relationS
8-2-337, Road No. 3, Banjara Hills, Hyderabad - 500034. Telangana, India. RICHA PERIWAL richaperiwal@drreddys.com priya K PRIYAK@drreddys.com
Dr. Reddy's receives positive CHMP opinion from European
Medicines Agency for AVT03 (denosumab), a Proposed Biosimilar of
Hyderabad India; September 22, 2025- Dr. Reddy's Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY; along with its subsidiaries together referred to as "Dr. Reddy's"), today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending marketing authorisation for AVT03, a biosimilar of Prolia (denosumab) and Xgeva (denosumab) in European markets.
As part of the established approval process, the CHMP positive opinion will now be reviewed by the European Commission (EC), following which a decision will be made on the grant of marketing authorisation in the European Economic Area (EEA), which includes the European Union (EU) member countries, in addition to Norway, Iceland and Liechtenstein. A Marketing Authorisation Application (MAA) for submission to the UK Medicines and Healthcare products Regulatory Agency (MHRA) will be made separately in keeping with the reliance route under the International Recognition Procedure (IRP).
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 glucocorticoid [1]. Xgeva is a prescription medicine used to prevent bone complications in adults with advanced cancer involving bone and for the treatment of adults and skeletally mature adolescents with giant cell tumour of bone [2].
In May 2024, Dr. Reddy's and Alvotech entered into a license and supply agreement for the commercialization of AVT03. Under the agreement, Alvotech will develop and manufacture AVT03, while Dr. Reddy's is responsible for registration and commercialization in applicable markets, including the U.S. and Europe. Dr. Reddy's commercialization rights are exclusive for the U.S., and semi-exclusive for Europe and the UK. 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.
AVT03 is a human monoclonal IgG2 antibody and biosimilar candidate to Prolia and Xgeva , which are both denosumab but in different presentations. Denosumab targets and binds with high affinity and specificity to the RANK ligand membrane protein, preventing the RANK ligand/RANK interaction from occurring, resulting in reduced osteoclast numbers and function, thereby decreasing bone resorption and cancer-induced bone destruction[1].
Prolia and Xgeva are registered trademarks of Amgen Inc.
About Dr. Reddy's: Dr. Reddy's Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY) is a global pharmaceutical company headquartered in Hyderabad, India. Established in 1984, we are committed to providing access to affordable and innovative medicines. Driven by our purpose of Good Health Can't Wait', we offer a portfolio of products and services including APIs, generics, branded generics, biosimilars and OTC. Our major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology. Our major markets include - USA, India, Russia & CIS countries, China, Brazil and Europe. As a company with a history of deep science that has led to several industry firsts, we continue to plan ahead and invest in businesses of the future. As an early adopter of sustainability and ESG actions, we released our first Sustainability Report in 2004. Our current ESG goals aim to set the bar high in environmental stewardship; access and affordability for patients; diversity; and governance.
Over the last 25 years, our Biologics team has developed into a fully integrated organization with robust capabilities in the development, manufacture and commercialization of a range of biosimilar products in oncology and immunology. We have a current portfolio of six commercial products marketed in India, with some products marketed in more than 30 other countries. In addition, we have several products in the pipeline in oncology and auto-immune diseases in various stages of development for global launches across developed as well as emerging markets. We are also ramping up manufacturing capacity to support our global expansion plans. In 2024, we launched our first biosimilar in the United Kingdom, Versavo (biosimilar bevacizumab). This follows our launch of pegfilgrastim in the U.S and Europe through our partner. Our biosimilars business has a key role to play in driving both near-term and long-term growth.
For more information, log on to: www.drreddys.com.
Disclaimer: This press release may include statements of future expectations and other forward-looking statements that are based on the management's current views and assumptions and involve known or unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. In addition to statements which are forward-looking by reason of context, the words "may", "will", "should", "expects", "plans", "intends", "anticipates", "believes", "estimates", "predicts", "potential", or "continue" and similar expressions identify forward-looking statements. Actual results, performance or events may differ materially from those in such statements due to without limitation, (i) general economic conditions such as performance of financial markets, credit defaults , currency exchange rates, interest rates, persistency levels and frequency / severity of insured loss events, (ii) mortality and morbidity levels and trends, (iii) changing levels of competition and general competitive factors, (iv) changes in laws and regulations and in the policies of central banks and/or governments, (v) the impact of acquisitions or reorganization, including related integration issues, and (vi) the susceptibility of our industry and the markets addressed by our, and our customers', products and services to economic downturns as a result of natural disasters, epidemics, pandemics or other widespread illness, including coronavirus (or COVID-19), and (vii) other risks and uncertainties identified in our public filings with the Securities and Exchange Commission, including those listed under the "Risk Factors" and "Forward-Looking Statements" sections of our Annual Report on Form 20-F for the year ended March 31, 2025. The company assumes no obligation to update any information contained herein.

Frequently Asked Questions

What is AVT03 by Dr. Reddy's?

AVT03 is a proposed biosimilar of denosumab, intended to treat osteoporosis and cancer-related bone issues.

What recent approval did Dr. Reddy's receive for AVT03?

The European Medicines Agency's CHMP issued a positive opinion for AVT03's marketing authorization.

What role does Alvotech play for AVT03?

Alvotech will develop and manufacture AVT03, while Dr. Reddy's handles registration and commercialization.

Which markets will Dr. Reddy's target with AVT03?

Dr. Reddy's aims to commercialize AVT03 in the U.S., Europe, and the UK.

What is the significance of denosumab?

Denosumab targets RANK ligand, reducing bone resorption and aiding in osteoporosis and cancer care.

Last updated: Sep 22, 2025