Zydus Lifesciences Limited, a prominent global life-sciences company, in collaboration with Formycon AG, an independent developer of biosimilars, has announced that the US Food and Drug Administration (USFDA) has accepted the Biologics License Application (BLA) for FYB206. This proposed biosimilar to Keytruda® (pembrolizumab) marks the first publicly announced acceptance of such an application by the USFDA, according to the companies. The BLA was submitted in the third quarter of 2026, and under the Biosimilar User Fee Amendments, the USFDA is expected to complete its review by the third quarter of 2027.
FYB206 was developed following a unique pathway agreed upon with the USFDA, which did not require a comparative Phase III efficacy trial. This innovative approach allowed for an accelerated development process, reducing investment while maintaining rigorous scientific standards. Zydus holds exclusive commercialisation rights for FYB206 in the United States and Canada, leveraging its extensive experience in the North American market. The regulatory dossier for FYB206 has also been submitted to Health Canada, indicating a strategic push to expand access to this oncology treatment across North America.
Dr. Sharvil P. Patel, Managing Director of Zydus Lifesciences, emphasised the significance of the USFDA’s acceptance, highlighting the potential of FYB206 to improve patient access to affordable pembrolizumab therapy. The collaboration with Formycon aims to strengthen Zydus’s oncology biosimilars portfolio, addressing the rising demand for high-quality, accessible cancer treatments. Dr. Stefan Glombitza, CEO of Formycon AG, echoed this sentiment, noting the milestone achievement in advancing a biosimilar to one of the world’s best-selling biologic medicines.
Keytruda®, an immune checkpoint inhibitor used in treating various cancers, remains a leading biologic medicine with substantial sales figures. In 2025, global sales of Keytruda® and its subcutaneous formulation, Keytruda Qlex™, reached USD 31.7 billion. This collaboration between Zydus and Formycon represents a significant step in making effective cancer therapies more accessible. Analysts and market observers will be closely watching the USFDA’s review process and its potential impact on the biosimilars market, particularly in light of the growing need for cost-effective biologic treatments.
