'Beyond Biosimilars to New Drugs'... US FDA Approves Celltrion's 'Jimpentra' New Drug

'Remsima SC' Developed as Biosimilar
FDA Approval as New Drug with 'Formulation Change' Weapon
"3 Trillion KRW Annual Sales Within 3 Years" Blockbuster Expected

Celltrion's biosimilar (biopharmaceutical generic) 'Remsima (generic name infliximab)' subcutaneous (SC) formulation 'Zymfentra (RemsimaSC, U.S. brand name)' has succeeded in obtaining approval from the U.S. Food and Drug Administration (FDA) as a new drug beyond a biosimilar. It is expected to become the vanguard for Celltrion's grand integrated vision of "KRW 12 trillion annual sales and KRW 5 trillion in new drug sales by 2030."

Celltrion announced on the 23rd that it received final marketing approval for Zymfentra from the FDA on the 20th. Although the FDA's notification deadline was originally set for the 28th, the approval was notified about a week earlier.

Zymfentra is a drug containing infliximab, used to treat autoimmune diseases such as inflammatory bowel disease (IBD), rheumatoid arthritis, and ankylosing spondylitis by inhibiting tumor necrosis factor (TNF)-alpha (α). After consulting with local medical staff in Europe, Celltrion Group Chairman Seo Jung-jin judged that there was a high need for an SC formulation to improve convenience and directly instructed its development. It was developed as the first and only infliximab SC formulation drug to replace the existing intravenous (IV) formulation. Additionally, it reduces patients' hospital visits, thereby lessening their time and economic burdens.

It has already been approved and sold under the brand name 'RemsimaSC' in more than 50 countries including Europe and Canada. Notably, unlike other regions where it was approved as a biosimilar, it was approved as a 'new drug' in the U.S., which is considered highly significant. The company explained that from the approval negotiation stage, the FDA recognized the uniqueness of the SC formulation among infliximab drugs and recommended the new drug approval process.

Expected Blockbuster with Annual Sales of KRW 3 Trillion

Zymfentra is expected to be the spearhead of Celltrion's ambitious goal of "KRW 12 trillion in annual sales and KRW 5 trillion in new drug sales by 2030." Chairman Seo Jung-jin previously stated, "Zymfentra will be sold at a price at least four times higher and protected by patents for 15 years, so there is little concern about price reductions of the original product," adding, "It is expected to grow into a blockbuster drug with a market size of KRW 700 billion in 2024 and over KRW 3 trillion by 2030." The company forecasts sales of KRW 600 billion in the U.S. and KRW 230 billion in Europe next year, and expects KRW 3 trillion in sales within three years. They also anticipate maintaining market dominance through patents until as late as 2040.

Seo Jung-jin, Chairman of Celltrion Group, is holding a meeting with investors at the 21st Morgan Stanley Global Healthcare Conference held in New York, USA.
[Photo by Celltrion]

Previously, in Europe, the combined market share of Remsima and RemsimaSC reached 68.5%, with RemsimaSC alone exceeding 17% market share in the five major European countries (EU5), indicating expected synergy with Remsima. In the U.S., Remsima's market share exceeded 30% as of the second quarter, and with Zymfentra's approval, significant synergy is anticipated. Furthermore, the company explained that Zymfentra is supplied through Celltrion Healthcare's direct sales network established via its U.S. subsidiary, Celltrion USA. Once the ongoing merger between Celltrion and Celltrion Healthcare is completed, the intermediate purchase-sale process by Celltrion Healthcare will be eliminated, enabling cost competitiveness and higher profitability.

According to IQVIA, a pharmaceutical market research firm, the U.S. TNF-α inhibitor market including infliximab was valued at $47.736 billion (approximately KRW 62.057 trillion) last year, ranking among the largest worldwide. The inflammatory bowel disease (IBD) market, which Zymfentra primarily targets, is valued at $9.827 billion (about KRW 12.8 trillion). Including IBD patients treated with therapies other than TNF-α inhibitors, the total U.S. IBD target market expands to approximately $21.8 billion (about KRW 28.3 trillion).

Zymfentra was approved for indications including Crohn's disease (CD) and ulcerative colitis (UC), major IBD conditions. This approval came about eight months after successfully presenting Phase 3 clinical trial results at the European Crohn's and Colitis Organisation (ECCO) conference held in Copenhagen, Denmark, in February, and approximately ten months after the approval application was submitted in December last year. In clinical trials involving 343 Crohn's disease patients and 438 ulcerative colitis patients over 54 weeks, Zymfentra demonstrated statistically superior efficacy compared to placebo in the primary endpoint of clinical remission and endoscopic response rate (CD), as well as all major secondary endpoints, while confirming similar safety.

Incheon Songdo Celltrion Plant 2 Overview. / Incheon - Photo by Hyunmin Kim kimhyun81@

A Celltrion official stated, "This Zymfentra approval marks the first milestone toward achieving integrated Celltrion's KRW 12 trillion sales target by 2030," adding, "Zymfentra is expected to drive integrated Celltrion's future sales growth and become a global blockbuster, so we will do our best to succeed in the U.S." The official also noted, "The market establishment of new products including Zymfentra and the development of five new biosimilar pipelines to be launched by 2025 are progressing smoothly, so integrated Celltrion's growth is expected to accelerate further."

This content was produced with the assistance of AI translation services.