Zydus Lifesciences532321Regulatory approval

USFDA accepts for review FYB206, a proposed Keytruda biosimilar; decision could come in Q3 2027

USFDA accepts for review the BLA for FYB206, a proposed Keytruda biosimilar.

By ScoutQuest · Tue 13 Oct 2026, 9:50 AM IST · 2 min read

USFDA Action: USFDA accepts for review the BLA for FYB206, a proposed Keytruda biosimilar
BLA Submission: The BLA was submitted in the third quarter of 2026
Expected Decision: a decision could be expected in the third quarter of 2027

The USFDA 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 USFDA of a update for a proposed Keytruda biosimilar.
FYB206 was developed without a comparative Phase III efficacy trial, following a development pathway agreed upon with the USFDA in early 2025.
The BLA was submitted in the third quarter of 2026.
A regulatory dossier for FYB206 has also been submitted to Health Canada.

Under the Biosimilar User Fee Amendments (BsUFA), the USFDA aims to complete its review within twelve months of submission.
This comprises up to 60 days for the update review and 10 months for the substantive review.
Based on this timeline, a decision could be expected in the third quarter of 2027.

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 update the regulatory dossiers, and supplying the product.
With the USFDA'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 issues, and holds exclusive commercialisation rights for the United States and Canada.
Formycon holds the global rights to FYB206 and will participate in the gross profits of its commercialisation partners.

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 totalled USD 16.40 billion.
According to the IQVIA Institute, 118 biologic medicines with sales of USD 232 billion will lose their exclusivity in the U.S. 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.

FYB206 is an investigational product and has not received regulatory approval in any country. Biosimilarity has not been established by regulatory authorities and is not claimed.
The release states that certain statements may constitute forward-looking statements that involve a number of risks and uncertainties, and that actual future business, financial condition, results of operations and prospects may differ materially.

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