Celltrion, Samsung Bioepis Battle Over Keytruda Biosimilar
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
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.
Written by urgent.news from BusinessKorea's reporting — not their text. Machine-written — may contain errors; check the original before relying on it.
