Prolia and Xgeva are used to prevent skeletal-related events in adults with advanced cancers. Credit: Perfect Wave/ Shutterstock.com

Alvotech has entered a collaboration with Dr Reddy’s Laboratories for the commercialisation of AVT03 in the US, Europe and the UK.

AVT03 is a biosimilar candidate to the reference products Prolia and Xgeva (denosumab).

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Prolia and Xgeva are used to treat conditions including osteoporosis in postmenopausal women and to prevent skeletal-related events in adults with advanced cancers.

The agreement will leverage Dr Reddy’s global commercial reach and Alvotech’s biosimilar development expertise.

Alvotech will be tasked with the development and manufacturing of AVT03.

Dr Reddy’s Laboratories will handle the registration and commercialisation of the product in the designated markets.

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The strategic collaboration comes with an undisclosed upfront payment to Alvotech, followed by regulatory and commercial milestone payments, as well as payments based on product sales.

The commercialisation rights granted to Dr Reddy’s are solely for the US market and semi-exclusive for the UK and European markets.

AVT03 is currently an investigational product and not approved by any regulatory agency.

In January 2024 Alvotech reported positive top-line data from a pharmacokinetic study of AVT03 against Prolia in healthy adults.

The study focused on the biosimilar’s pharmacokinetics, safety and tolerability.

Further trials are in progress, including a confirmatory efficacy and safety study in patients and a pharmacokinetic study comparing AVT03 to Xgeva.

Dr. Reddy’s CEO Erez Israeli stated: “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.”

The latest development comes after Alvotech and Teva Pharmaceuticals obtained US Food and Drug Administration approval for Selarsdi (ustekinumab-aekn) via subcutaneous injection.