Alvotech and Dr. Reddy's to Commercialize Biosimilar in US, Europe, and UK

Alvotech and Dr. Reddy's Laboratories announced a collaboration for the commercialization of AVT03, Alvotech's biosimilar candidate to denosumab. Under the agreement, Alvotech will be responsible for the development and manufacturing of the product, while Dr. Reddy's will handle its registration and commercialization in the U.S., Europe, and the UK.

The license and supply agreement includes an upfront payment to Alvotech, with additional payments tied to regulatory and commercial milestones, as well as sales-based compensation. Dr. Reddy's will have exclusive commercialization rights in the United States and semi-exclusive rights in Europe and the United Kingdom.

AVT03 is a biosimilar candidate to Prolia® and Xgeva®, used for treating conditions such as osteoporosis and preventing skeletal-related events in patients with advanced malignancies. In January 2024, Alvotech reported positive top-line results from a pharmacokinetic study comparing AVT03 to Prolia®. A confirmatory efficacy and safety study in patients is currently underway, along with a pharmacokinetic study comparing AVT03 to Xgeva®.

The partnership aims to combine Dr. Reddy's global commercial network with Alvotech's biosimilar development and manufacturing capabilities. The collaboration intends to increase patient access to cost-effective biologic medications across multiple global markets.