Alvotech has formed a collaboration with India-based Dr. Reddy’s Laboratories to co-develop, produce, and market a biosimilar version of Keytruda (pembrolizumab) for international markets.
Listed on Nasdaq, Alvotech is a biotechnology firm focused on biosimilar medicines. Dr. Reddy’s Laboratories is a pharmaceutical company based in India.
The partnership aims to leverage the strengths of both companies in biosimilars, thereby accelerating development processes and expanding global distribution.
Keytruda, a product of Merck Sharp & Dohme (MSD), is prescribed for treating multiple cancer types. In 2024, the worldwide sales of Keytruda reached $29.5bn.
The biosimilar candidate will combine the expertise of Alvotech and Dr. Reddy’s Laboratories to potentially enhance access to this important medication.
Alvotech chairman and CEO Róbert Wessman said: “This agreement demonstrates Alvotech’s ability to leverage its dedicated R&D and manufacturing platform for biosimilars, accelerating the expansion of our pipeline by pursuing growing global markets. It further enables us to increase the availability of cost-effective, critical biologic medications to patients worldwide.”
Pembrolizumab is a humanised monoclonal antibody targeting the programmed cell death-1 (PD-1) receptor, blocking its interaction with PD-L1 and PD-L2 ligands. By inhibiting these interactions, it enhances T-cell immune responses, including anti-tumour effects, which may be expressed by tumour or other cells in the tumour microenvironment.
The agreement details that both Alvotech and Dr. Reddy’s Laboratories will share the responsibility of developing and manufacturing the biosimilar candidate while dividing associated costs and duties. Subject to specific conditions, each company holds the right to globally commercialise the product.
Dr. Reddy’s Laboratories CEO Erez Israeli said: “We are happy to collaborate with Alvotech for the pembrolizumab biosimilar. This demonstrates our ability to develop and manufacture high quality and affordable treatment options for patients worldwide.
“Additionally, oncology has been a top focus therapy area for us and this collaboration will further enhance our capabilities in oncology, as pembrolizumab currently represents one of the most critical therapies in immuno-oncology.”
