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Celltrion files for approval of Keytruda biosimilar, joining domestic race

Published

24 August 2026

Topic

opportunities

Sectors

Biotech

Geography

South Korea

Source

Read at m.ajupress.com

Verified

Fusion42 · 24 August 2026 · Fusion42 review

Celltrion applied for South Korean regulatory approval of CT-P51, a biosimilar version of Merck's Keytruda, joining a domestic race with Samsung Bioepis to capture market share as the original drug's patent expires. The company confirmed pharmacokinetic equivalence in trials and plans to seek approvals in the US, Europe, and Canada.

This Wire brief sits within Fusion42's coverage of Biotech.

◆ The Wire takeaway

You face a fiercely competitive market as South Korea fast-tracks biosimilar approvals for blockbuster cancer drugs. Move now to explore partnerships or accelerate development to secure early market access before rivals solidify dominance.

Coverage

1 source · 24 Aug 2026

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Topics

Biotechbiosimilarsdrug-approvalsouth-koreaimmuno-oncologykeytruda