Zydus, Formycon Hit Major USFDA Milestone for First USD 31 Billion Keytruda Biosimilar

According to Zydus, this marks the first publicly announced acceptance by the USFDA of a regulatory filing for a Keytruda® biosimilar. The BLA was submitted during the third quarter of 2026. Under the framework of the Biosimilar User Fee Amendments (BsUFA), the USFDA aims to complete its review process within twelve months of submission, comprising up to 60 days for filing review and 10 months for substantive review. Based on this established timeline, a final regulatory decision is anticipated in the third quarter of 2027. A corresponding regulatory dossier for FYB206 has also been formally submitted to Health Canada.

Dr Sharvil P. Patel, Managing Director of Zydus Lifesciences Limited, said: “Acceptance of the application marks a significant step toward expanding access to affordable pembrolizumab therapy in the U.S. and Canada. As demand for high-quality, accessible oncology treatments continues to rise, FYB206 has the potential to improve patient access and outcomes while strengthening our oncology biosimilars portfolio. Leveraging the biologics expertise of Formycon and our established oncology platform in North America, we remain focused on delivering meaningful value to patients.”

Dr Stefan Glombitza, CEO of Formycon AG, said: “With the FDA’s acceptance of the FYB206 application for review, we are among the very first companies to advance a biosimilar to the world’s bestselling biologic medicine to this stage. We developed FYB206 on a path agreed with the FDA, without conducting a comparative Phase III efficacy trial. This enabled us to accelerate the program and substantially reduce development investment while maintaining the rigorous scientific standards required for biosimilar approval. With Zydus, we have a partner with strong commercial capabilities and a clear oncology strategy in the US and Canada. Together, we aim to make this important cancer therapy accessible to more patients.”

Pembrolizumab functions as an immune checkpoint inhibitor that binds to and blocks the PD-1 receptor, allowing it to treat numerous types of cancer. The reference drug, Keytruda®, currently remains the world’s best-selling biologic medicine. In 2025, worldwide sales of Keytruda®, including its subcutaneous formulation Keytruda Qlex™, reached USD 31.7 billion. In the first half of 2026, combined global sales for Keytruda® and Keytruda Qlex™ totaled USD 16.40 billion.

The development trajectory of FYB206 was streamlined in February 2025 after Formycon reached an agreement with the USFDA establishing that the candidate did not require a comparative Phase III efficacy trial. Subsequently, in December 2025, Formycon and Zydus entered into an exclusive licensing and supply agreement for FYB206 covering the United States and Canada.

Under the terms of the agreement, Formycon is responsible for completing product development, preparing and filing regulatory dossiers, and supplying the clinical and commercial product. With the USFDA’s formal acceptance of the BLA for review, Formycon has fulfilled a key regulatory milestone that entitles it to a milestone payment from Zydus. Subject to regulatory approval and the resolution of any underlying intellectual property issues, Zydus will handle the commercialization of FYB206 in both North American markets. Formycon retains overall global rights to FYB206 and will participate in the gross profits generated by its commercialization partners.

The companies behind the filing bring substantial research and commercial infrastructure to the collaboration. Zydus Lifesciences Limited is an innovation-led life-sciences enterprise with leadership positions across pharmaceuticals and consumer wellness, supported by an emerging MedTech franchise and a global operational footprint spanning the United States, India, and other international markets. The group employs 30,000 people worldwide, including 1,500 scientists dedicated to research and development, and operates with a mission to unlock new possibilities in life sciences through quality healthcare solutions.

Formycon AG is a publicly listed, independent developer of biosimilars based in Martinsried, a prominent life science hub outside Munich, Germany. Formycon employs 200 professionals from 27 countries covering the full development chain, from laboratory analysis and manufacturing to clinical testing and regulatory documentation. The company currently has three biosimilars approved across ophthalmology and immunology marketed worldwide through commercial partners, alongside four additional candidates in active development, including biosimilars to two of the world’s highest-grossing biologic drugs.

The filing comes amid a broader shift in global biopharmaceuticals toward biosimilars, which are successor products developed from the ground up to demonstrate no clinically meaningful differences from reference biologics in safety and efficacy. According to data from the IQVIA Institute, 118 biologic medicines representing USD 232 billion in sales are projected to lose market exclusivity in the U.S. alone by 2034, with biosimilar development programs currently underway for only twelve of those therapies. In Europe, biosimilar adoption has already delivered EUR 75 billion in cumulative healthcare savings and enabled over seven billion treatment days for patients.