India Pharma Outlook Team | Thursday, 01 January 2026
Dr. Reddy's Laboratories has been hit by a regulatory challenge in the United States, when its wholly owned subsidiary, Dr. Reddy's Laboratories SA, Switzerland, was issued a Complete Response Letter (CRL) by the US Food and Drug Administration, regarding its Biologics License Application (BLA) of AVT03 (denosumab).
AVT03 is a potential biosimilar to the popular biologic drugs Prolia and Xgeva that were created by Amgen and were discovered by biopharmaceutical company Alvotech hf. The company claimed that the CRL was granted upon the findings of the USFDA after a pre-licence inspection of the manufacturing plant of Alvotech in Reykjavik, Iceland.
The feedback of the regulator is also associated with manufacturing and inspection-related factors and does not relate to the clinical effectiveness or safety information provided in the application.
Also Read: Amneal Pharma Wins FDA Nod for Denosumab Biosimilars
The use of denosumab-based therapies has become widespread in the treatment of osteoporosis and bone-related complications in cancer patients, and as a result, the US market presents a critical growth opportunity among the developers of biosimilars.
An effective approval would have enhanced the presence of Dr. Reddy in the high-value biologics segment, which is one of the core markets through which the company plans to grow in the future.
Dr. Reddy’s Hyderabad Laboratories is an international pharmaceutical giant that operates in the United States, Europe, India and other developing economies. The company has a wide portfolio in terms of active pharmaceutical ingredients (APIs), generic formulations, branded generics, biosimilars, and over-the-counter products. It claimed that it will collaborate with Alvotech to correct the observations made by the USFDA and take the appropriate corrective actions.
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