Zydus Lifesciences, in collaboration with Formycon AG, an independent biosimilar developer, announced that the U.S. Food and Drug Administration (USFDA) has accepted the Biologics License Application (BLA) for the proposed biosimilar to Merck's Keytruda (pembrolizumab) for review.
Keytruda is one of the best-selling biological drugs globally, showing worldwide sales of $16.4 billion in the first half of this year and projected to exceed $31 billion in 2025.