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Alvotech and Dr. Reddy’s have announced FDA acceptance of their Biologics License Application for AVT03, a biosimilar to denosumab, marking a key step towards providing a more affordable treatment option for bone diseases.
On 18 March 2025, the biopharmaceutical firm Alvotech and global pharma leader Dr. Reddy’s Laboratories Ltd. announced that the United States Food and Drug Administration (FDA) has formally accepted for review their Biologics License Application (BLA) for AVT03, a proposed biosimilar referencing monoclonal antibody denosumab.
Targeting a Growing Need in Bone Disease Therapies
AVT03 is being developed as a biosimilar to denosumab, a widely prescribed biologic that plays a critical role in the care of bone diseases. Denosumab is primarily indicated for mitigating osteoporosis in postmenopausal females and males at elevated risk of fracture. It is also approved for skeletal-related complications prophylaxis in those with bone metastases from solid tumors and in adults and adolescents with giant cell tumor of bone. The availability of a cost-effective biosimilar alternative like AVT03 is anticipated to improve patient access in the U.S., where denosumab continues to be a high-cost therapy with significant demand.
Two Formulations, Broad Coverage
Pending FDA approval, AVT03 will be made available in two dosage forms:
A Strategic Alliance for U.S. Commercialization
The FDA submission follows a licensing and supply agreement signed in May 2024 between Alvotech and Dr. Reddy’s. Under the terms of this deal:
This partnership is part of Dr. Reddy’s broader push into the biosimilar segment, building on its strong presence in the U.S. generics space.
What’s Next?
With the BLA now under FDA review, the companies await regulatory feedback, including a possible advisory committee meeting. If approved, AVT03 could launch in the U.S. in 2025 or early 2026, subject to market exclusivity expiration and patent considerations around denosumab.
Alvotech
Alvotech and Dr. Reddy’s Announce FDA acceptance of Biologic License Application for AVT03, a Proposed Biosimilar to Prolia® and Xgeva®
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