Formycon first to enter FDA review in $42B Keytruda biosimilar race

The FDA has accepted for review a Keytruda biosimilar application from Germany's Formycon and India's Zydus Lifesciences — the first publicly announced FDA review of such a filing. A decision is expected in Q3 2027, with at least 13 companies, including Samsung Bioepis and Celltrion, racing to market.

• Keytruda generated about $31.7 billion in 2025 sales
• Formycon skipped a large Phase 3, relying on analytical and PK data
• Samsung Bioepis ran a 555-patient Phase 3 and filed in South Korea
• Keytruda's core US patent expires in December 2028