Celltrion's 'Remsima SC' Applies for New Drug Approval from FDA

The World's First and Only Subcutaneous Injection Formulation of Infliximab
Significantly Enhanced Convenience by Changing from Intravenous Injection
Applying for 'New Drug Approval' as a 'Biobetter' Not a 'Biosimilar'

Celltrion's autoimmune disease treatment 'Remicade' biosimilar 'RemsimaSC' (Photo by Celltrion)

[Asia Economy Reporter Lee Chun-hee] Celltrion announced on the 23rd that it completed the new drug application to the U.S. Food and Drug Administration (FDA) on the 22nd (local time) for ‘Remsima SC,’ an infliximab subcutaneous (SC) formulation autoimmune disease treatment. A Celltrion official explained, "Since this is not a typical biosimilar (biopharmaceutical generic) but has undergone formulation changes, we were advised by the FDA to proceed with a new drug application, and thus we submitted the application."

Remsima is a biosimilar of Remicade, a tumor necrosis factor (TNF)-alpha (α) inhibitor used to treat autoimmune diseases. Celltrion first biosimilarized Remsima in an intravenous (IV) form as ‘Remsima IV’ and then successfully developed a biobetter in the subcutaneous (SC) form. To date, it is the only SC formulation product among both the original and biosimilars, and since SC generally offers greater dosing convenience and safety than IV, it is emerging as a new treatment option. It has already obtained marketing approval in over 40 countries, including the Korean Ministry of Food and Drug Safety and the European Medicines Agency (EMA), and was advised by the FDA to proceed with the new drug approval process, leading to this application.

Celltrion submitted the approval to the FDA based on efficacy and safety results obtained from global Phase 3 clinical trials conducted on patients with ulcerative colitis and Crohn’s disease. The trials involved 438 ulcerative colitis patients and 343 Crohn’s disease patients, divided into Remsima SC treatment groups and placebo groups, with results analyzed up to 54 weeks. The results showed that Remsima SC demonstrated statistically significant superior efficacy compared to the control group in both cases. Safety was also confirmed, showing no meaningful difference from the placebo group.

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

Celltrion expects that if Remsima SC, which emphasizes formulation convenience, obtains approval in the U.S., it will enable broad and rapid penetration in the TNF-α inhibitor market through synergy with Remsima IV. According to medical information provider Symphony Health, Remsima IV (sold under the name ‘Inflectra’ in the U.S. through Pfizer) recorded a 31.7% market share as of the third quarter.

According to pharmaceutical market research firm IQVIA, the global market size for TNF-α inhibitors was $58.8 billion (approximately 75 trillion KRW) last year, with the U.S. market accounting for the largest share at $42.786 billion (approximately 55 trillion KRW). The inflammatory bowel disease (IBD) market in the U.S., which is expected to be the main target for Remsima SC, also reaches $21.872 billion (approximately 28 trillion KRW).

In particular, since the application was submitted as a new drug, it is expected that upon approval, Remsima SC will be able to set higher prices than other biosimilars by leveraging new drug status. Currently, Celltrion Healthcare, which handles overseas sales of Celltrion products, is establishing a direct sales system in the U.S., so profitability is expected to increase further.

Celltrion is also working on securing patent rights for Remsima SC. Patents related to the formulation and administration method have been filed in major countries including the U.S. and Europe. Once registration is completed, exclusive rights are expected to be maintained until around 2037.

A Celltrion official said, “Remsima SC is already rapidly expanding its influence in Europe, where it has achieved a market share of 12%. Securing new drug status in the U.S., the world’s largest infliximab market, will not only strengthen the position of the Remsima product line but also provide more patients with opportunities for high-quality pharmaceutical treatment.”

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