Alvotech & Dr. Reddy's Partner for Denosumab Biosimilar

Hyderabad, May 21 (PTI) Alvotech, a global biotech company and a subsidiary of Dr. Reddy's Laboratories on Tuesday have entered into a licence and supply agreement for the commercialisation of AVT03, the latter's biosimilar candidate to Prolia and Xgeva (denosumab).

A press release from Dr Reddy's said the collaboration combines the city-based drug maker's global commercial presence with Alvotech's proven capabilities in developing biosimilars for markets worldwide.

AVT03 is a human monoclonal antibody and biosimilar candidate to Prolia and Xgeva, which are both denosumab but in different presentations.


Prolia and Xgeva are indicated for the treatment of various diseases including osteoporosis in post-menopausal women and prevention of skeletal-related events in adults with advanced malignancies.


Alvotech will be responsible for development and manufacturing of the product while Dr. Reddy's will be working for registration and commercialisation of the product in the applicable markets.


The licence 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, the release said.


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 US, Europe and UK. Over the years, we have created a portfolio of biosimilar products, which are marketed in several emerging markets."

"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.