ARTICLE
31 July 2026

Celltrion Targets European Secukinumab Market With EMA Filing For CT-P55

GP
Goodwin Procter LLP

Contributor

At Goodwin, we partner with our clients to practice law with integrity, ingenuity, agility, and ambition. Our 1,600 lawyers across the United States, Europe, and Asia excel at complex transactions, high-stakes litigation and world-class advisory services in the technology, life sciences, real estate, private equity, and financial industries. Our unique combination of deep experience serving both the innovators and investors in a rapidly changing, technology-driven economy sets us apart.
Celltrion has submitted a Marketing Authorization Application to the European Medicines Agency for CT-P55, its biosimilar candidate to Novartis' blockbuster drug COSENTYX. The application seeks approval across all European indications including multiple autoimmune conditions, following earlier regulatory filings in Canada and South Korea.
Worldwide Food, Drugs, Healthcare, Life Sciences
Wendy Leben’s articles from Goodwin Procter LLP are most popular:
  • within Food, Drugs, Healthcare and Life Sciences topic(s)
  • with readers working within the Pharmaceuticals & BioTech industries
Goodwin Procter LLP are most popular:
  • within Criminal Law, Strategy and Accounting and Audit topic(s)

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.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

[View Source]

Mondaq uses cookies on this website. By using our website you agree to our use of cookies as set out in our Privacy Policy.

Learn More