Alvotech and Dr Reddy’s collaborate to develop a Keytruda biosimilar. Alvotech completes its Xbrane R & D acquisition and expands its Advanz Pharma partnership, accelerating biosimilar development and global commercialization.
In June 2025, Alvotech and Dr Reddy’s Laboratories announced that they had entered into a collaboration and license agreement to co-develop, manufacture and commercialize a biosimilar candidate to Keytruda (pembrolizumab) for global markets. This follows Alvotech’s recent completion of its transaction with Xbrane Biopharma AB, which included the acquisition of Xbrane’s R&D organization and a biosimilar candidate for Cimzia (certolizumab pegol) [1]. Additionally, in May 2025, Alvotech and Advanz Pharma announced that they have entered into an agreement to expand their commercial partnership to cover three additional biosimilar candidates.
Merck/MSD’s Keytruda (pembrolizumab) is a humanized monoclonal antibody (derived from mouse) that binds to and blocks PD-1 on lymphocytes. It is an anticancer medication used in the treatment of melanoma, lung cancer, head and neck cancer, Hodgkin lymphoma, urothelial cancer (cancer of the bladder and urinary tract) and renal cell carcinoma (kidney cancer) [2]. In 2024, worldwide sales of Keytruda were almost US$30 billion.
The Alvotech-Dr Reddy’s collaboration hopes to speed-up the development processes and extend the global reach for their pembrolizumab biosimilar candidate. Under the terms of the agreement, the companies will be jointly responsible for developing and manufacturing the pembrolizumab biosimilar candidate, sharing costs and responsibilities. Subject to certain exceptions, the companies will have the right to commercialize the product globally.
In early June, Alvotech completed its acquisition of Sweden’s Xbrane Biopharma AB’s R & D operations and a biosimilar candidate for Cimzia (certolizumab pegol), which had been announced in March 2025 [1]. The transaction entails a total purchase price of approximately SEK 275 million (US$28.9 million), and includes parts of Xbrane’s organization, including approximately 40 employees and R & D operations based in Campus Solna, at the Karolinska Institute outside Stockholm, Sweden. The acquisition is expected to expand Alvotech's development capacity and establish a strong presence in the Swedish life science sector.
Additionally, Alvotech and UK-based Advanz Pharma expanded their agreement to cover the supply and commercialization in Europe of biosimilar candidates for Novartis’s Ilaris (canakinumab), a human antibody interleukin-1β blocker indicated for the treatment of various inflammatory diseases, and Kesimpta (ofatumumab), a biosimilar of Genmab/ GlaxoSmithKline's Arzerra and a CD20-directed cytolytic antibody indicated for the treatment of relapsing forms of multiple sclerosis [4], in addition to a third undisclosed biosimilar candidate. Alvotech will be responsible for development and commercial supply and Advanz Pharma will be responsible for European registration and commercialization. The agreement includes development and commercial milestones for the three products and totals up to approximately US$180 million.
Alvotech has already established partnerships with Dr Reddy’s and Advanz Pharma. For example, in partnership with Dr Reddy’s, Alvotech secured FDA acceptance for AVT03, a biosimilar to Prolia/Xgeva (denosumab). Separately, through partnerships with Kashiv Biosciences and Advanz Pharma, the company gained UK approval for AVT23, a biosimilar to Xolair (omalizumab) [1].
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References
1. GaBI Online - Generics and Biosimilars Initiative. Alvotech acquires Xbrane [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Jun 30]. Available from: www.gabionline.net/pharma-news/alvotech-acquires-xbrane
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of pembrolizumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Jun 30]. Available from: www.gabionline.net/biosimilars/general/biosimilars-of-pembrolizumab
3. GaBI Online - Generics and Biosimilars Initiative. Rituximab gets US FDA approval for chronic lymphocytic leukaemia [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Jun 30]. Available from: www.gabionline.net/biosimilars/news/Rituximab-gets-US-FDA-approval-for-chronic-lymphocytic-leukaemia
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