Celltrion files IND for Humira biosim interchangeability trial in U.S.

[Source: Celltrion Inc.]

Celltrion has filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for a global Phase 3 clinical trial to demonstrate the interchangeability of its biosimilar Yuflyma with original drug Humira (adalimumab).

The global clinical trial is designed to compare treatment outcomes of those who receive Humira and Yuflyma in a crossover fashion and those who maintain Humira treatment to verify the pharmacokinetics, efficacy, and safety of Yuflyma in 366 patients with plaque psoriasis, the Korean company said in a regulatory filing on Monday.

Yuflyma, the world¡¯s first high-concentration adalimumab biosimilar authorized by the European Medicines Agency (EMA), is expected to give more convenience to patients for its reduced dosing. It is also citrate-free, meaning the biosimilar causes less pain after administration compared to Humira.

Celltrion plans to launch Yuflyma in the United States, the world¡¯s largest pharmaceutical market, next year. The interchangeability test, if successful, means the biosimilar¡¯s complete replaceability with its reference drug at pharmacies, thereby enhancing its competitiveness against other Humira biosimilars.

Yuflyma has already received approval for all indications of Humira, including rheumatoid arthritis, inflammatory bowel disease, and psoriasis, and sales have started in major European countries.

Meanwhile, Ildong Pharmaceutical, another Korean pharmaceutical company, announced on Monday it has initiated a Phase 1 study of its investigational nonalcoholic steatohepatitis (NASH) drug codenamed ID119031166M in California.

The company said that the Phase 1 clinical trial protocol okayed by the FDA on July 29 will use a dose escalation scheme to determine the maximum tolerated dose in healthy volunteers. The candidate drug is known to work by regulating the metabolism of bile acids, which are related to fat accumulation, inflammation, and fibrosis in the liver.

[¨Ï Maeil Business Newspaper & mk.co.kr, All rights reserved]