Zydus Completes Agenus Deal, Launches US-Based Biologics CDMO Arm Zylidac Bio

Commenting on the finalisation of the deal, Dr Sharvil P. Patel, Managing Director of Zydus Lifesciences Limited, stated, “With this deal, Zylidac Bio LLC will now provide biological manufacturing sites offering CDMO services to biopharmaceutical companies globally. This supports the evolving landscape of biological product manufacturing in the U.S., which prioritises secure, domestic, and high-quality supply chains for advanced therapies. Zylidac Bio LLC offers a critical, compliant solution for global innovators and allows for a localised supply chain. It reinforces our ability to serve the international biopharmaceutical industry with reliability and innovation.”

Dr Garo Armen, Chairman and CEO of Agenus Inc., said, “This collaboration unites Agenus’ pioneering immunotherapy pipeline and U.S.-based clinical development capabilities with Zydus’ global manufacturing, operational scale, and commercial infrastructure. The transaction allows Agenus to monetise manufacturing assets while securing dedicated, high-quality U.S. biologics capacity to support botensilimab and balstilimab. Importantly, it sharpens our focus on advancing BOT and BAL through late-stage development and expanding paid access to patients globally who have limited treatment options.”

The launch of Zylidac Bio LLC is particularly significant in light of the BIOSECURE Act, signed into law on December 18, 2025, which restricts U.S. executive agencies from contracting with “biotechnology companies of concern”. By establishing a secure, domestic manufacturing footprint in California through Zylidac Bio LLC, Zydus provides a “safe harbour” for global biopharmaceutical companies seeking to transition their supply chains to compliant, U.S.-based partners.

Earlier in 2025, Zydus announced Global BioCDMO Services through the acquisition of Agenus Inc.’s state-of-the-art facilities in Emeryville and Berkeley. Under the exclusive manufacturing agreement, Zydus will be the sole provider for the production of drug substance and drug product for Agenus Inc.’s Phase III immuno-oncology candidates, botensilimab (BOT) and balstilimab (BAL). Zydus has also secured exclusive rights to commercialise Agenus’ lead immuno-oncology assets, BOT and BAL, in India and Sri Lanka.

Zydus completed its equity investment in Agenus Inc. through its venture capital arm, Zynext Ventures. This move complements Zydus’ recently announced strategic partnership with Formycon to commercialise a Keytruda® biosimilar (FYB206) in North America. Zylidac Bio LLC will enable a localised supply chain, ensuring agility and security for Zydus’ expanding biosimilar and innovative portfolio.

Zydus Lifesciences Limited is an innovation-led life sciences company with leadership positions across pharmaceuticals and consumer wellness, supported by an emerging MedTech franchise and a global footprint across the United States, India, and other international markets. As of September 30, 2025, the group employs over 29,000 people worldwide, including 1,500 scientists engaged in research and development, and is driven by its mission to unlock new possibilities in life sciences through quality healthcare solutions that impact lives.