{
  "id": 3227247,
  "title": "Celltrion, Samsung Bioepis Battle Over Keytruda Biosimilar",
  "url": "https://urgent.news/2026/08/25/celltrion-samsung-bioepis-battle-over-keytruda-biosimilar",
  "topic": "health",
  "section": "Health & Medicine",
  "published": "2026-08-25T09:10:16.000Z",
  "source": {
    "name": "BusinessKorea",
    "slug": "businesskorea",
    "url": "https://www.businesskorea.co.kr/news/articleView.html?idxno=275493"
  },
  "original_language": "en",
  "account": "As the patent for the top-selling Keytruda drug nears expiration, South Korea's Celltrion and Samsung Bioepis are locked in a fierce competition to be the first with a biosimilar. Celltrion, which has the advantage of fast-track approval, has applied for domestic product clearance for its CT-P51 biosimilar. Their clinical trial with 228 melanoma patients showed the biosimilar to be pharmacokinetically equivalent to the original and safe. Samsung Bioepis, meanwhile, is launching a counterattack with its SB27 biosimilar, boasting large-scale phase 3 clinical data from over 600 patients with non-small cell lung cancer. This indicates they aim to secure early prescription reliability and dominate the global market worth 44 trillion won. Keytruda's patent expiration presents a crucial battleground, with the first biosimilar to hit the market potentially securing a dominant position in the global immunotherapy market. Both companies are strategically using their unique strengths - Celltrion's in-house production and direct sales distribution, and Samsung Bioepis' robust global partnerships - to secure their place in the global biosimilar arena.",
  "summary": "As the patent expiration of the global top-selling mega blockbuster drug ‘Keytruda (ingredient name pembrolizumab)’ approaches, South Korea’s two biotechnology giants, Celltrion and Samsung Bioepis, have entered a life-or-death head-to-head battle.Celltrion, which has taken the lead in domestic and",
  "key_points": [
    "Celltrion leads biosimilar race with CT-P51, approved via fast-track",
    "Samsung Bioepis counters with SB27, backed by phase 3 data from 600+ patients",
    "Patent expiry in September creates crucial market battleground"
  ],
  "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."
}