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HYDERABAD, India and REYKJAVIK, Iceland — Alvotech and Dr. Reddy’s Laboratories SA have entered into a license and supply agreement for the commercialization of AVT03, Alvotech’s biosimilar candidate to Prolia and Xgeva (denosumab).
The collaboration combines Dr. Reddy’s global commercial presence with Alvotech’s proven capabilities in developing biosimilars for markets worldwide. Prolia and Xgeva are indicated for the treatment of various diseases including osteoporosis in postmenopausal women, and prevention of skeletal-related events in adults with advanced malignancies.
Alvotech will be responsible for developing and manufacturing the product. Dr. Reddy’s will be responsible for registration and commercialization in the applicable markets. The license and supply agreement includes an upfront payment to Alvotech, with additional payments upon certain regulatory and commercialization milestones as well as sales-based payments.
Dr. Reddy’s commercialization rights are exclusive for the U.S., and semi-exclusive for Europe and the UK.
Erez Israeli, chief executive officer of Dr. Reddy’s, said: “We are pleased to collaborate with Alvotech to make this denosumab biosimilar available to patients in the U.S., Europe and UK. Over the years, we have created a portfolio of biosimilar products, which are marketed in several emerging markets. Most recently, we launched bevacizumab, our first biosimilar in the UK. This strategic collaboration augments our growing portfolio of biosimilar offerings, and progresses our biosimilar journey further into the highly regulated markets. We look forward to leveraging our strong commercial capabilities in these markets to ensure patients receive access to best-in-class therapies and affordable treatment options.”
“We are proud to announce this new strategic partnership, that will enable us to increase the availability of cost-effective, critical biologic medications across multiple markets worldwide,” said Robert Wessman, chairman and CEO of Reykjavík-based Alvotech. “Dr. Reddy’s shares our commitment to provide better access to safe and effective biologics. Biosimilars play an increasingly important role in global healthcare systems, offering broader access to best-in-class therapies. Combining our resources will ensure that patients globally can be better served.”
AVT03 is a human monoclonal antibody and biosimilar candidate to Prolia and Xgeva, which are both denosumab but in different presentations. Prolia is indicated for the treatment of osteoporosis in postmenopausal women and for bone loss in adult men and women at increased risk of fracture.
Xgeva is indicated for prevention of skeletal-related events such as pathological fractures in adults with advanced malignancies involving bone. In January, Alvotech announced positive top-line results from a pharmacokinetic (PK) study which assessed the pharmacokinetics, safety, and tolerability of AVT03 compared to Prolia® in healthy adult subjects. A confirmatory efficacy and safety study for AVT03 in patients is currently underway, as well as a PK study comparing AVT03 to Xgeva in healthy adult subjects. AVT03 is an investigational product and has not received regulatory approval in any country. Biosimilarity has not been established by regulatory authorities and is not claimed.
