USFDA Accepts Review for First Keytruda Biosimilar Candidate

Developed by Germany-based Formycon and slated for North American commercialization by Zydus Lifesciences, the candidate reached this milestone without the need for a comparative Phase III efficacy trial. This streamlined development pathway, negotiated with federal regulators in early 2025, allowed the companies to accelerate their timeline and reduce project costs while maintaining established scientific standards for biosimilar approval.

Under the Biosimilar User Fee Amendments, the agency aims to complete its assessment within twelve months, potentially leading to a final decision by the third quarter of 2027. While the drug remains under investigation, its progress targets a significant market segment; Keytruda generated over 31 billion dollars in global sales during 2025. Zydus and Formycon have also submitted regulatory dossiers to Health Canada, positioning the product for a broader expansion across North America as they navigate the remaining intellectual property and clinical requirements.