Interchangeability test for Celltrion's Humira biosim cleared in Estonia

[Source: Celltrion Inc.]

South Korea’s Celltrion Inc. will launch a Phase 3 clinical trial to test interchangeability of its biosimilar Yuflyma against reference drug Humira (adalimumab) in Estonia upon approval from the health authorities in Europe, the company said on Tuesday.

The trial will evaluate the pharmacokinetics, efficacy, and safety of the biosimilar in 366 patients with plaque psoriasis across Europe for a follow-up period of 13 months until November of next year to demonstrate its interchangeability to the reference.

If they are replaceable, pharmacists can prescribe refills for Humira with Yuflyma without the intervention of physicians. Global data to show interchangeability can be used for submission to the FDA and will be of great help to expand Celltrion’s market share in the adalimumab market, the company said.

Celltrion submitted Investigational New Drug (IND) approval for Yuflyma codenamed CT-P17 to the United States and Europe in summer.

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.

Celltrion also completed a patent license agreement with Humira developer AbbVie in the U.S. and aims to launch Yuflyma from July of next year after the FDA’s approval within this year.

Humira sales amounted to $20.69 billion last year, of which $17.33 billion was generated in the U.S. alone.

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