Zydus moves closer to US launch of Keytruda biosimilar
What Happened
The US FDA has accepted for review the Biologics License Application for FYB206, a proposed biosimilar to Merck’s cancer drug Keytruda (pembrolizumab), developed by Formycon with Zydus Lifesciences. According to the companies, it is the first publicly announced FDA acceptance of a Keytruda biosimilar application.
Key Takeaways
Zydus holds exclusive commercialisation rights for FYB206 in the US and Canada. The FDA decision could come in Q3 2027, although acceptance for review does not mean the product has been approved.