Dr Reddys Laboratories , a global pharmaceutical company headquartered in Hyderabad, India, has achieved a significant milestone in its biosimilar development program. The company announced that it has received a positive opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) for AVT03, a proposed biosimilar of denosumab.

Key Highlights

• AVT03 is a biosimilar candidate to Prolia® and Xgeva®, both denosumab products
• The CHMP positive opinion is a crucial step in the European approval process
• Upon approval, Dr. Reddy's will market the biosimilar under the tradenames Acvybra® and Xbonzy®

Regulatory Pathway

The positive CHMP opinion will now be reviewed by the European Commission (EC). Following this review, a decision will be made on granting marketing authorization in the European Economic Area (EEA), which includes the European Union member countries, Norway, Iceland, and Liechtenstein.

Dr. Reddy's also plans to submit a separate Marketing Authorisation Application (MAA) to the UK Medicines and Healthcare products Regulatory Agency (MHRA) through the reliance route under the International Recognition Procedure (IRP).

About AVT03

AVT03 is a human monoclonal IgG2 antibody and biosimilar candidate to Prolia® and Xgeva®. Denosumab targets and binds with high affinity and specificity to the RANK ligand membrane protein, reducing osteoclast numbers and function, thereby decreasing bone resorption and cancer-induced bone destruction.

Commercial Strategy

Dr. Reddy's entered into a license and supply agreement with Alvotech for the commercialization of AVT03. Under this agreement:

• Alvotech will develop and manufacture AVT03
• 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

Potential Market Impact

The positive CHMP opinion for AVT03 represents a significant advancement in Dr. Reddy's biosimilar portfolio. Denosumab is a widely used medication for treating osteoporosis and preventing skeletal-related events in patients with bone metastases. The introduction of a biosimilar version could potentially increase access to this important therapy and offer cost savings to healthcare systems.

As Dr. Reddy's continues to expand its presence in the biosimilar market, this development underscores the company's commitment to providing affordable and innovative medicines globally. The company's growing biosimilar portfolio, which now includes six commercial products marketed in India and other countries, positions it as a significant player in the evolving biosimilar landscape.

With the potential approval of AVT03, Dr. Reddy's is poised to strengthen its foothold in the European pharmaceutical market and further its mission of accelerating access to high-quality, affordable medications for patients worldwide.

Dr Reddys Laboratories , a leading Indian pharmaceutical company, has announced a significant change in its shareholding structure as part of a succession planning initiative. On September 17, 2025, the company's promoters, Satish Reddy Kallam and G V Prasad, transferred a combined 20.58% stake to their respective family trusts through off-market transactions.

Details of the Transfer

The transfer involved a total of 17,17,26,540 equity shares, each with a face value of Rs. 1. The specifics of the transaction are as follows:

• Satish Reddy Kallam transferred 7,56,30,620 shares (9.06% stake) to the VSD Family Trust.
• G V Prasad transferred 9,60,95,920 shares (11.51% stake) to the GVP Family Trust.

Shareholding Impact

This transfer has resulted in significant changes to the individual holdings of the promoters:

It's important to note that despite these changes, the aggregate promoter group holding remains unchanged at 26.64%.

Regulatory Compliance

The transfer was conducted under an exemption provided by the Securities and Exchange Board of India (SEBI) through an order dated December 31, 2024 (reference number WTM/ASB/CFD/16/2024-25). This exemption was granted specifically for the purpose of succession planning and streamlining family assets.

Purpose and Implications

According to the company's disclosure, this transfer is part of a private family arrangement aimed at ensuring smooth succession planning and more efficient management of family assets and businesses. The move is seen as a strategic step to secure the long-term interests of the company and its founding families.

Market Response

As of the announcement, there were no immediate significant changes reported in the company's stock price or market capitalization. The transfer is largely viewed as an internal restructuring that does not affect the overall promoter stake or company operations.

Conclusion

This development at Dr Reddys Laboratories highlights the growing trend among Indian corporates to use trust structures for succession planning. While the day-to-day operations of the company are unlikely to be affected, this move ensures a clear line of succession and potentially more streamlined decision-making processes within the promoter group in the future.

Investors and market watchers will likely keep a close eye on any further developments or changes in the company's management structure following this significant shareholding transfer.