Celltrion Files EU Approval for Cosentyx Biosimilar CT-P55

Celltrion said on July 24 that it has filed a marketing authorization application with the European Medicines Agency (EMA) for CT-P55, a biosimilar version of Novartis's autoimmune treatment Cosentyx, known generically as secukinumab.

The application covers every indication for which Cosentyx is approved in Europe, including plaque psoriasis, psoriatic arthritis, ankylosing spondylitis and juvenile idiopathic arthritis. Celltrion said earlier clinical trials had already demonstrated pharmacokinetic equivalence between CT-P55 and the original drug, along with comparable safety and immunogenicity profiles.

CT-P55 works by inhibiting interleukin-17A, a protein involved in inflammatory responses that underlie a range of autoimmune conditions. Cosentyx, developed by Swiss pharmaceutical giant Novartis, generated roughly $6.67 billion in global sales last year, making it one of the best-selling drugs in its class.

The European filing follows Celltrion's first regulatory submission for CT-P55 in Canada in May, followed by an application in South Korea in June. With approval processes now underway in three major markets, the company is positioning itself to launch among the earliest biosimilar competitors to Cosentyx once patents and regulatory exclusivity periods allow.

A Celltrion official said the company has begun in earnest the approval procedures needed to enter key global markets, adding that it aims to quickly build the commercial groundwork to be part of the "first wave" of biosimilars to launch.

The secukinumab biosimilar market is estimated at around 10 trillion won ($6.7 billion) globally, making it one of the more lucrative targets in Celltrion's expanding immunology portfolio. Being among the earliest biosimilar entrants typically confers a pricing and market-share advantage before competition intensifies.