{
  "id": 14594551,
  "title": "Formycon First to Enter FDA Review in $42 Billion Keytruda Biosimilar Race",
  "url": "https://urgent.news/2026/10/15/formycon-first-to-enter-fda-review-in-42-billion-keytruda-biosimilar",
  "topic": "health",
  "section": "Health & Medicine",
  "published": "2026-10-15T02:54:55.000Z",
  "source": {
    "name": "BusinessKorea",
    "slug": "businesskorea",
    "url": "https://www.businesskorea.co.kr/news/articleView.html?idxno=278871"
  },
  "original_language": "en",
  "account": null,
  "summary": "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.",
  "key_points": [],
  "editors_take": null,
  "illustration": null,
  "coverage": {
    "outlets": 1,
    "also_reported_by": []
  },
  "ai_generated": true,
  "disclaimer": "Summaries, key points and the editor’s take are written by software from other outlets’ reporting and may contain errors — always check the linked original."
}