Dr Reddy's Denosumab Biosimilar AVT03 Faces USFDA Setback After Plant Inspection
New Delhi: Drug major Dr Reddy's Laboratories Limited's wholly owned subsidiary, Dr. Reddy's Laboratories SA, Switzerland, has received a Complete Response Letter (CRL) from the United States Food and Drug Administration (USFDA) for its Biologics License Application (BLA) for AVT03 (denosumab).
AVT03 is a proposed biosimilar candidate to Amgen’s blockbuster brands Prolia and Xgeva, and is being developed by Alvotech hf, with Dr. Reddy’s as its commercialization partner for certain markets.
In a regulatory disclosure filed under Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015, the company stated:
“Dr. Reddy's Laboratories SA, Switzerland, wholly owned subsidiary of the Company (‘Dr. Reddy’s Swiss’) has received a Complete Response Letter (CRL) from the United States Food and Drug Administration (USFDA) for its Biologics License Application (BLA) for AVT03 (denosumab), a proposed biosimilar candidate to Prolia® & Xgeva®, developed by Alvotech hf (‘Alvotech’).”
According to the filing, the CRL does not relate to the clinical efficacy or safety data of the product, but is linked to manufacturing-related observations.
“The CRL refers to the observations from a pre-license inspection of Alvotech’s Reykjavik manufacturing facility,” the company disclosed.
A Complete Response Letter is issued by the USFDA when it determines that it cannot approve a marketing application in its present form. Such letters typically outline deficiencies that must be addressed before approval can be reconsidered, including issues related to manufacturing facilities, processes, or documentation.
Denosumab is a monoclonal antibody used in the treatment of osteoporosis and bone-related complications in cancer patients. Prolia® is indicated for osteoporosis and bone loss, while Xgeva is used to prevent skeletal-related events in patients with bone metastases from solid tumors. Both products are among the highest-revenue biologics globally, making biosimilar development strategically significant.
Dr. Reddy’s disclosure was addressed to multiple exchanges, including the National Stock Exchange of India, BSE Limited, the New York Stock Exchange, and NSE IFSC, reflecting the material nature of the regulatory update for investors.
Dr. Reddy’s Laboratories Limited, headquartered in Hyderabad, is a global pharmaceutical company with a strong presence in generics, biosimilars, and specialty products across key international markets, including the United States.
