Alvotech, an Iceland-headquartered biotech company specialising in the development and manufacture of biosimilar medicines for patients worldwide, and Dr. Reddy’s Laboratories SA, wholly-owned subsidiary of Hyderabad-based Dr. Reddy’s Laboratories, have entered into a license and supply agreement for the commercialisation 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 commercialisation 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 commercialisation milestones as well as sales-based payments. Dr. Reddy’s commercialisation rights are exclusive for the US, and semi-exclusive for Europe and the UK.

Erez Israeli, Chief Executive Officer of Dr. Reddy’s, said “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."