Celltrion Joins South Korea's Keytruda Biosimilar Race with CT-P51 Filing

Celltrion has filed for approval of its biosimilar version of Merck's Keytruda, known as CT-P51, with South Korea's Ministry of Food and Drug Safety. This move comes about two weeks after rival Samsung Bioepis submitted its own Keytruda biosimilar, SB27, for domestic approval.

Keytruda is a blockbuster cancer drug that generated $31.7 billion in global sales last year, making it the world's top-selling drug. CT-P51 has been confirmed pharmacokinetically equivalent to the reference drug through a trial involving 228 melanoma patients.

Celltrion plans to pursue approvals in the United States, Europe, and Canada once it receives domestic approval, which industry watchers expect as early as next year due to the regulator's efforts to shorten new-drug reviews to within 240 days.