Dr. Reddy's Laboratories has disclosed receiving a regulatory setback from the United States Food and Drug Administration regarding its biosimilar development program. The pharmaceutical company announced that its wholly owned subsidiary Dr. Reddy's Laboratories SA, Switzerland has received a Complete Response Letter for its AVT03 biosimilar application.

Regulatory Development Details

The Complete Response Letter pertains to the Biologics License Application for AVT03, which is a proposed biosimilar candidate to denosumab products Prolia and Xgeva. The CRL specifically refers to observations from a pre-license inspection of Alvotech's Reykjavik manufacturing facility. The biosimilar has been developed in partnership with Alvotech hf, an Iceland-based biopharmaceutical company specializing in biosimilar development.

Manufacturing Facility Inspection

The CRL specifically references observations arising from a pre-license inspection conducted at Alvotech's manufacturing facility located in Reykjavik. Pre-license inspections are routine regulatory procedures where the FDA evaluates manufacturing facilities to ensure compliance with current Good Manufacturing Practices before approving new drug applications.

About AVT03 Biosimilar

AVT03 represents Dr. Reddy's entry into the denosumab biosimilar market. Denosumab is a monoclonal antibody used for treating osteoporosis and preventing skeletal-related events in patients with bone metastases from solid tumors. The reference products Prolia and Xgeva are established treatments in the bone health therapeutic area.

Partnership Structure

The biosimilar development involves a collaboration between Dr. Reddy's Swiss subsidiary and Alvotech hf. This partnership structure allows Dr. Reddy's to leverage Alvotech's biosimilar development expertise while utilizing its own regulatory and commercial capabilities for market access.

Regulatory Disclosure

The announcement was made under Regulation 30 of the SEBI Listing Obligations and Disclosure Requirements Regulations, 2015, ensuring transparency with stakeholders regarding material regulatory developments.

Dr Reddy's Laboratories has announced that its board of directors will convene on January 21, 2026 to consider and approve the company's Q3FY26 financial results. The pharmaceutical major will release results for the quarter and nine months ended December 31, 2025, following standard corporate governance practices.

Board Meeting and Results Release

The company has formally notified stakeholders about the upcoming board meeting through a regulatory filing under Regulation 30. The results will be announced after the board meeting concludes, with distribution across multiple channels including stock exchanges, media, and the company website.

Earnings Call Schedule

Following the results announcement, Dr Reddy's Laboratories management will host an earnings call to discuss the company's financial performance. The call is scheduled for January 21, 2026 at 19:30 PM IST (9:00 AM ET).

Stakeholder Access

The company will make comprehensive information available to stakeholders through multiple formats. A press meet presentation will be accessible on the company website, while both audio recordings and transcripts of the earnings call will be made available post-event on the company website and filed with stock exchanges.

As one of India's prominent pharmaceutical companies, Dr Reddy's Laboratories' quarterly results are closely monitored by investors, analysts, and industry observers for insights into operational performance and financial health during the reporting period.