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Dr. Reddy's and Alvotech Partner to Develop Keytruda Biosimilar in $29.5 Billion Market

  • Dr. Reddy's Laboratories and Alvotech have entered a collaboration and license agreement to co-develop, manufacture, and commercialize a biosimilar version of Keytruda (pembrolizumab) for global markets.
  • Keytruda generated $29.5 billion in sales globally in 2024 and is indicated for the treatment of numerous cancer types including lung cancer and melanoma.
  • The partnership aims to combine both companies' biosimilar capabilities to accelerate development and expand global access to this critical immuno-oncology therapy.
  • Under the agreement, both parties will share development and manufacturing costs and responsibilities, with each having rights to commercialize the product globally subject to certain exceptions.
Dr. Reddy's Laboratories has announced a strategic partnership with Alvotech, a global biotech firm focused on biosimilar medicines, to co-develop, manufacture, and commercialize a biosimilar version of Keytruda (pembrolizumab) for global markets. The collaboration targets one of the world's most successful cancer drugs, which generated $29.5 billion in sales globally in 2024.

Strategic Partnership Details

Under the terms of the collaboration and license agreement, both parties will jointly share development and manufacturing responsibilities and costs for the biosimilar candidate. Subject to certain exceptions, each company will have the right to commercialize the product globally, leveraging their combined expertise in biosimilar development.
The partnership aims to accelerate the development process by combining Dr. Reddy's and Alvotech's capabilities in biosimilars while extending global reach for this critical therapy. Keytruda is indicated for the treatment of numerous cancer types, including lung cancer and melanoma, making it a cornerstone of modern immuno-oncology treatment.

Executive Perspectives

Róbert Wessman, Chairman and CEO of Alvotech, emphasized the strategic value of the collaboration: "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 world-wide."
Erez Israeli, CEO of Dr Reddy's, highlighted the alignment with the company's therapeutic focus: "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."

Market Impact and Access

Pembrolizumab functions as an immune checkpoint inhibitor commonly prescribed for various types of cancer treatment. The development of a biosimilar version aims to provide a more affordable alternative while maintaining therapeutic efficacy, aligning with broader efforts to improve accessibility to advanced oncology treatments globally.
The collaboration represents a significant move in the biosimilar space, targeting one of the highest-revenue cancer drugs and potentially expanding patient access to this critical immuno-oncology therapy through more cost-effective treatment options.
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