Celltrion is accelerating the development of follow-on biosimilars for autoimmune diseases as it seeks to secure new long-term growth drivers. The company plans to expand its autoimmune disease portfolio by adding follow-on pipelines with diverse mechanisms of action to its existing core products.

According to industry sources on Aug. 4, Celltrion recently filed for U.S. Food and Drug Administration (FDA) approval of CT-P55 (ingredient: secukinumab), a treatment for autoimmune diseases. CT-P55 is the most advanced of Celltrion's follow-on autoimmune disease pipeline products in terms of commercialization.

Celltrion has been accelerating its push into major global markets, filing for approval of CT-P55 in Canada in May, South Korea in June, the European Medicines Agency (EMA) in July and now the United States.

The latest filing is part of Celltrion's "first-group" strategy. The company aims to secure regulatory approvals for a biosimilar of Cosentyx, a blockbuster drug that generated about $6.67 billion in global sales last year, ahead of competitors in major markets and capture early market share.

Autoimmune diseases occur when the immune system attacks the body's own healthy tissues, causing chronic inflammation and tissue damage. Treatments are developed to selectively regulate specific immune pathways or cells that trigger inflammation, with mechanisms of action varying according to the target.

Because treatment responses can vary depending on the disease and target, having therapies with diverse mechanisms of action is considered a key competitive advantage in the global market.

Celltrion is expanding its autoimmune disease portfolio accordingly. The company has already commercialized the TNF-alpha inhibitors Remsima, Remsima SC (U.S. brand name Zymfentra) and Yuflyma, and has expanded its lineup with the launches of Steqeyma, an IL-12/23 inhibitor, and Avtozma, an IL-6 inhibitor.

Development of follow-on pipelines is also continuing. In addition to CT-P55, the biosimilar of Cosentyx for which regulatory applications have recently been filed in major markets, Celltrion is conducting a global Phase 3 trial of CT-P53, a biosimilar of Ocrevus.

Development is also underway for CT-P45, a biosimilar of Entyvio; CT-P52, a biosimilar of Taltz; and CT-P68, a biosimilar of Tremfya, for which Celltrion recently received approval for its clinical trial application in South Korea. Through these programs, the company is building an autoimmune disease portfolio spanning a range of mechanisms of action, including TNF-alpha, IL-17A, IL-23, CD20 and integrins.

Beyond autoimmune diseases, Celltrion has expanded its biosimilar business into oncology, ophthalmic diseases and urticaria, among other areas, and has launched a total of 11 products in global markets. The company plans to increase its biosimilar portfolio to 18 products by 2030 and a total of 41 products by 2038.

"Regulatory filings for CT-P55 in major global markets demonstrate that our strategy to expand our autoimmune disease portfolio is beginning to deliver tangible results," a Celltrion official said. "We will advance the clinical development and commercialization of our follow-on pipelines without disruption to expand treatment options for patients and healthcare professionals."

Celltrion is accelerating the development of follow-on biosimilars for autoimmune diseases …

Celltrion accelerates mechanism diversification strategy, expands autoimmune disease portfolio