Celltrion has submitted a Marketing Authorization Application to the European Medicines Agency (“EMA”) for CT-P55, its biosimilar to Novartis’ COSENTYX® (secukinumab). The application covers all indications held by COSENTYX® in Europe, including plaque psoriasis, psoriatic arthritis, axial spondyloarthritis, juvenile idiopathic arthritis, and hidradenitis suppurativa. According to Celltrion, CT-P55 has demonstrated pharmacokinetic equivalence to COSENTYX® and similar safety and immunogenicity profiles in clinical trials. The European submission follows earlier filings for CT-P55 in Canada (May 2026) and South Korea (June 2026). COSENTYX® recorded global sales of approximately $6.7 billion last year. If approved, CT-P55 would expand Celltrion’s autoimmune disease biosimilar portfolio—which already includes TNF-α, IL-6, and IL-12/23 inhibitors—to include an IL-17A inhibitor.
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