Zydus Lifesciences and Formycon has jointly announced 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).

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. Sharvil P Patel, Managing Director, Zydus Lifesciences, 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.”

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.

Dr. Stefan Glombitza, CEO, 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 3 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.”

In the first half of 2026, combined sales of Keytruda and Keytruda Qlex totaled USD 16.40 billion.

Keytruda therefore remains the world’s best-selling biologic medicine. In February 2025, Formycon agreed with the FDA that FYB206 does not require a comparative phase 3 efficacy trial.

In December 2025, Formycon and Zydus had entered into an exclusive licensing and supply agreement for FYB206 in the US 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 commercialise FYB206 in both markets, subject to regulatory approval and resolution of any Intellectual Property (IP) issues. Formycon holds the global rights to FYB206 and will participate in the gross profits of its commercialisation partners.