Formycon First to Enter FDA Review in $42 Billion Keytruda Biosimilar Race
The global race to capture a share of the market for biosimilars of Keytruda, the world’s top-selling drug by revenue, has reached a key regulatory milestone in the United States. Germany’s Formycon has become the first company to publicly announce that the U.S. Food and Drug Administration has acce
Formycon has become the first company to publicly announce that the U.S. Food and Drug Administration has accepted its Keytruda biosimilar application for review, signaling the start of the regulatory process in the $42 billion Keytruda biosimilar race. The German company has opted to forgo a large-scale comparative Phase 3 efficacy trial, instead focusing on analytical and functional comparability assessments and a comparative pharmacokinetic study, which is expected to save costs and shorten the development timeline.
Other contenders in the race include South Korean companies Samsung Bioepis and Celltrion, which are pursuing different approaches, such as completing a global Phase 3 trial and applying for approval in South Korea, or reducing the size of their Phase 3 trial after receiving FDA approval for a smaller sample size.
Brief written by urgent.news from BusinessKorea's own syndicated text. Machine-written — may contain errors; check the original before relying on it.
