Celltrion’s Remsima SC was approved in the US

company's first new drug to be approved in the US

First subcutaneous injection formulation of Remicade approved in the US

Celltrion “expects annual sales of KRW 600 billion, and KRW 3 trillion in sales within 3 years”

Pic of ZYMFENTRA

On the 23rd, Celltrion announced that it had received marketing authorization for Zymfentra, which is a subcutaneous formulation of its antibody biosimilar Remsima.

 

Remsima is a Remicade biosimilar.

 

Zymfentra has been approved in Europe under the product name Remsima SC.

 

Celltrion said, “Zymfentra is the world’s only infliximab SC formulation treatment developed by changing the formulation of Remsima, an existing intravenous formulation drug, to a subcutaneous injection to secure strong competitiveness in the TNF-alpha inhibitor market.

 

Remsima SC has obtained marketing authorization in approximately 50 countries, including Europe and Canada, and is rapidly expanding its share in the market.

 

Zymfentra is Celltrion's first product approved as a new drug in the US market.

 

According to Celltrion, the FDA recognized the product's differentiated value from the discussion stage and recommended it take the new drug approval process.

 

To obtain approval as a new drug, Celltrion conducted two new global Phase III clinical trials.

 

Based on the safety and efficacy results demonstrated through the clinical trials, Celltrion submitted an application for its approval in December of last year in accordance with the FDA's new drug approval process and obtained authorization in 10 months.

 

In the new Phase III trials that were conducted on 343 Crohn's disease patients and 438 patients with ulcerative colitis for 54 weeks, Zymfentra demonstrated statistically superior efficacy and comparable safety with placebo as maintenance therapy in all endpoints including the primary endpoint of clinical remission and endoscopic response rate, as well as the other major secondary endpoints.

 

The company said, “We expect to receive patent protection until 2040 through patents on the SC formulation and administration method that we have already filed patents for." This patent is a barrier patent designed to protect against the market entry of not only Zymfentra but also other infliximab subcutaneous injection biosimilars.

 

If the company successfully receives the patent, Zymfentra will be able to enjoy its exclusive status until patent expiry.

 

Through this, Celltrion expects that it will be able to set a higher selling price for Zymfentra than existing biosimilars, which will serve as a stable mid- to long-term profit base for the company.

 

According to IQVIA, a pharmaceutical market research firm, the size of the U.S.

 

TNF-alpha inhibitor market which includes infliximab, was USD 47.736 billion (approximately KRW 62 trillion) as of last year.

 

Celltrion believes it would be possible to achieve annual sales that exceed KRW 600 billion and KRW 3 trillion in sales within 3 years.

 

An official from Celltrion said, “Unlike existing new drugs, Zymfentra has already demonstrated its convenience and efficacy in major global markets including Europe, so it is expected to also show great success in the world’s largest pharmaceutical market.

 

the United States, Given the relatively poor medical environment in the United States, where patients lack economic and physical access to medical facilities, the inherent convenience of the SC formulation, which allows patients to administer the medication at home, will serve as a significant competitive advantage.”