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 on December 31, 2025, 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 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. The disclosure was signed by K Randhir Singh, Company Secretary, Compliance Officer & Head-CSR, on December 31, 2025.

Dr Reddy's Laboratories has announced that its board of directors will convene on January 21 to consider and approve the company's third quarter financial results. The pharmaceutical major has scheduled this important board meeting as part of its regular quarterly reporting cycle.

Board Meeting Details

The company has formally notified stakeholders about the upcoming board meeting, which will focus on reviewing and approving the financial performance for the third quarter. This announcement follows standard corporate governance practices for listed companies in India.

Market Significance

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

The scheduled board meeting represents a key milestone in the company's quarterly reporting timeline, allowing stakeholders to assess the pharmaceutical major's business progress and financial metrics for the quarter.