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Alvotech, Dr. Reddy’s collaborate for biosimilar candidate to Prolia, Xgeva

Alvotech will develop and manufacture the product, and Dr. Reddy’s will register and commercialize it in the applicable markets.

Dr. Reddy’s and Alvotech 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 capabilities in developing biosimilars for markets worldwide, the companies said.

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 develop and manufacture the product, and Dr. Reddy’s will register and commercialize it 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 U.K.

[Read more: Dr. Reddy’s debuts on Dow Jones Sustainability World Index]

Erez Israeli, CEO 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 U.K. 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 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."

[Read more: Dr. Reddy's acquires MenoLabs from Amyris]

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