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Celltrion Lays Out Europe Launch Plans, Strategy Following Remsima SC Approval

Multiple Indications, Markets In Sights

 
• By Jung Won Shin

Celltrion plans to launch its new subcutaneous formulation of Remsima in Europe next year beginning with Germany and then to get approvals for all indications by mid-2020. It has indicated that prices will be higher than first-line anti-TNF treatments but competitive with second-line rheumatoid arthritis treatments, as it pursues a strategy to gain substantial market share.

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Europe Remsima SC Launches To Start In Germany • Source: Shutterstock

Celltrion Inc. has received European Medicines Agency (EMA) approval for the world’s first subcutaneous (SC) biosimilar version of infliximab, Remsima SC, giving the South Korean company another foothold to evolve into a truly global enterprise, as it laid out its commercial plans and strategy for the roll-out in Europe.

The formal regulatory nod came after the company received a positive opinion in the EU in mid-September for its approval filing made a year ago. Remsima SC has passed through the marketing authorization extension route, given the lack of a formal pathway for "biobetters" in Europe

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