Celltrion’s subcutaneous injection infliximab wins FDA approval

Zymfentra [Courtesy of Celltrion]

Celltrion said on Monday its latest biosimilar Zymfentra was approved by the U.S. Food and Drug Administration (FDA). Zymfentra is a novel formulation of Remsima (infliximab), a biosimilar used in the treatment of autoimmune diseases, is administered via subcutaneous injection (SC). Celltrion has high expectations for the product, with Zymfentra forecast to achieve annual sales exceeding 600 billion won ($446 million) after its release.

Zymfentra represents a significant milestone for Celltrion, as it is the company’s first product to receive the “novel drug” approval in the U.S. The product has already gained sales approval in over 50 countries, including Europe and Canada, under the name Remsima SC. In the United States, the FDA recognized the product’s differentiating factors from the consultation stage for regulatory review and recommended the new drug approval process. To obtain this novel drug approval, Celltrion conducted two new global Phase 3 clinical trials.

Once the patent applications for the SC formulation and administration method are completed, Zymfentra is expected to enjoy patent protection until as late as 2040. This positions the product as a stable, long-term revenue generator until the patent expires. Celltrion anticipates that Zymfentra will enable the company to hit 3 trillion won in sales within three years.

Meanwhile, the merger proposal between Celltrion and Celltrion Healthcare received approval during a shareholder meeting held on Monday. The approval rate for on-site shareholders casting their votes in favor was 97.04 percent and 95.17 percent respectively. With this milestone, the two companies successfully navigated the meeting just over two months after formalizing their merger in August 2023. But their next hurdle is the opposition from shareholders against the merger, which must be addressed before the merger date of December 28.

Celltrion Group has set the limit for the claims for stock purchasing from shareholders against the merger that can be exercised until November 13 at 1 trillion won.

Notably, National Pension Service (NPS), one of Celltrion’s top shareholders, holds a 7.43 percent stake equivalent to 10.87 million shares, second only to the largest shareholder, Celltrion Holdings (20.05 percent). NPS refrained from voting for the merger proposal on Monday and if NPS exercises its claims for the entire stake, Celltrion would need to allocate 1.6 trillion won.