Formycon And Zydus: FYB206 Becomes First Publicly Announced Keytruda Biosimilar Accepted For Review By FDA

• The US Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for FYB206 for review; to the best of the companies’ knowledge, this is the first publicly announced acceptance by the FDA of a filing for a proposed biosimilar to Keytruda
• FYB206 was developed without a comparative Phase III efficacy trial, following a development pathway agreed upon with the FDA in early 2025
• The acceptance marks a regulatory milestone under the licensing agreement with Zydus Lifesciences Limited (Zydus), entitling Formycon to a milestone payment
• Zydus holds exclusive commercialization rights for the United States and Canada and brings extensive commercial experience in the North American market

Formycon, an independent developer of biosimilars, and Zydus Lifesciences Limited (Zydus), an innovation-led global life-sciences company, jointly announce that the US Food and Drug Administration (“FDA”) has accepted for review the Biologics License Application (“BLA”) for FYB206, a proposed biosimilar to Keytruda (pembrolizumab). To the best of the companies’ knowledge, this is the first publicly announced acceptance by the FDA of an application for a Keytruda biosimilar. The BLA was submitted in the third quarter of 2026. Under the Biosimilar User Fee Amendments (BsUFA), the FDA aims to complete its review within 12 months of submission, comprising up to 60 days for the filing review and 10 months for the substantive review. Based on this timeline, a decision could be expected in the third quarter of 2027. The regulatory dossier for FYB206 has also been submitted to Health Canada.

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 best-selling 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.”

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 US 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.”

In February 2025, Formycon agreed with the FDA that FYB206 does not require a comparative Phase III efficacy trial. Such a trial had long been standard for biosimilars of monoclonal antibodies; it typically takes one to three years and involves hundreds of patients. In its draft guidance of October 2025, the FDA proposed that comparative efficacy trials will generally no longer be required for therapeutic proteins. Development of FYB206 continued on the basis of a comprehensive analytical and functional comparability package and the pivotal Dahlia pharmacokinetic study, which met its primary objective in February 2026 and demonstrated pharmacokinetic equivalence between FYB206 and the reference product. Clinical development was completed in July 2026. Forgoing the Phase III trial is a key reason why FYB206 has reached FDA review this quickly, and it is expected to save investments in the high double-digit million euro range. This kind of lean development is one of the four pillars of the Formycon growth strategy #FYB4GROWTH.

In December 2025, Formycon and Zydus entered into an exclusive licensing and supply agreement for FYB206 in the United States and Canada. Formycon is responsible for completing development, preparing and filing the regulatory dossiers, and supplying the product. With the FDA’s acceptance of the BLA for review, Formycon has reached a regulatory milestone under the agreement that entitles it to a milestone payment from Zydus. Zydus will commercialize FYB206 in both markets, subject to regulatory approval and resolution of any intellectual property issues. Formycon holds the global rights to FYB206 and will participate in the gross profits of its commercialization partners. Beyond the US and Canada, Formycon has partnered FYB206 with MS Pharma for the MENA region and with Lotus for parts of Asia-Pacific. For all other regions, including Europe and Latin America, discussions with potential partners are ongoing.

Pembrolizumab is an immune checkpoint inhibitor that binds to and blocks the PD-1 receptor and is used to treat numerous types of cancer. In 2025, worldwide sales of Keytruda, including the subcutaneous formulation Keytruda Qlex, reached USD 31.7 billion. In the first half of 2026, combined sales of Keytruda and Keytruda Qlex totaled USD 16.4 billion. Keytruda remains the world’s best-selling biologic medicine.

About Formycon:
Formycon AG is a listed, independent developer of biosimilars based in Martinsried, one of the leading life science locations in Europe, just outside Munich, Germany. Its 200 employees from 27 countries cover the entire development chain, from laboratory analysis through manufacturing and clinical testing to the documents for approval. Three Formycon biosimilars are approved in ophthalmology and immunology and are marketed worldwide through commercialization partners. Four further candidates are in development, among them biosimilars to two of the best-selling biologic medicines in the world. With its products, Formycon makes highly effective therapies affordable for more people.

For more information, visit www.formycon.com.

About Zydus Lifesciences Limited:
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. The group employs 30,000 people worldwide, including 1,500 scientists engaged in research and development. Zydus is driven by its mission to unlock new possibilities in life sciences through quality healthcare solutions that improve lives. Further information is available at www.zyduslife.com.

About Biosimilars:
Biosimilars are successor products to biologic medicines. They are not copies; each one is developed from the ground up and must demonstrate to the health authorities that it has no clinically meaningful differences from the reference product in terms of safety and efficacy. According to the IQVIA Institute, 118 biologic medicines with sales of USD 232 billion will lose their exclusivity in the US alone by 2034, and for only twelve of them is a biosimilar in development. In Europe, biosimilars have saved EUR 75 billion and made more than seven billion days of treatment possible.