Mumbai: and Formycon AG jointly announced on Monday, 13 October 2026, that the (USFDA) has accepted for review the Biologics License Application (BLA) for FYB206. FYB206 is a proposed biosimilar to Keytruda (pembrolizumab).
Regulatory Acceptance
This acceptance marks the first publicly announced USFDA review of an application for a Keytruda biosimilar, according to the companies. The BLA was submitted in the third quarter of 2026.
Review Timeline
Under the Biosimilar User Fee Amendments (BsUFA), the USFDA aims to complete its review within twelve months of submission. This period includes up to 60 days for filing review and 10 months for substantive review. A decision is expected in the third quarter of 2027.
Market Rights and Development
Zydus holds exclusive commercialisation rights for in the United States and Canada. The regulatory dossier for FYB206 has also been submitted to Health Canada.
Strategic Importance
Sharvil P Patel, Managing Director of Zydus Lifesciences, said the application’s acceptance is a step towards expanding access to affordable pembrolizumab therapy in the U.S. and Canada. Stefan Glombitza, CEO of Formycon AG, noted that the FDA’s acceptance positions them among the first companies to advance a biosimilar to a top-selling biologic medicine.
Development Pathway
FYB206 was developed without a comparative Phase III efficacy trial, following a development pathway agreed upon with the USFDA in early 2025. This approach helped accelerate the programme and reduce development investment, according to Formycon.
Keytruda Sales
Worldwide sales of Keytruda, including the subcutaneous formulation Keytruda Qlex, reached USD 31.7 billion (approximately ₹2.64 lakh crore) in 2025. In the first half of 2026, combined sales totalled USD 16.40 billion (approximately ₹1.36 lakh crore), making Keytruda a world-leading biologic medicine.
Licensing Agreement
Formycon and Zydus entered into an exclusive licensing and supply agreement for FYB206 in the US and Canada in December 2025. Formycon is responsible for development, regulatory filings, and product supply, while Zydus will commercialise FYB206 in both markets.