Alvotech, Dr Reddy's collaborate for commercialization of AVT03 in US, Europe and UK

Hyderabad: Alvotech, a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, and Dr. Reddy's Laboratories SA, wholly-owned subsidiary of Dr. Reddy’s Laboratories Ltd., have announced that the companies 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 development and manufacturing of the product. Dr. Reddy’s will be responsible for registration and commercialization of the product 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.”