Celltrion said on Wednesday that it received approval from the FDA for its 80 mg and 20 mg dosage forms of Yuflyma, a biosimilar referencing Abbvie's Humira (ingredient: adalimumab), adding to the existing approval for the 40 mg dose. 

Humira, the original medicine, is prescribed primarily for autoimmune diseases such as rheumatoid arthritis, inflammatory bowel disease, and psoriasis. Yuflyma is FDA approved to treat eight conditions including Crohn’s disease and ulcerative colitis.

Yuflyma is characterized by a high-concentration formulation that halves the dose of the drug compared to the low concentration and eliminates citrate, which can cause pain. The availability of 80 mg doses is expected to cater to the needs of patients who require higher doses, and 20 mg for pediatric patients who require lower doses.

In the U.S., high-concentration formulations are increasingly prescribed due to their ease of administration. According to Symphony Health and IQVIA, high-concentration formulations accounted for more than 85 percent of adalimumab sold in the U.S. last year. 

Yuflyma's access to three different dosage forms, including both auto-injector (AI) and prefilled syringe (PFS) formats, will broaden the range of eligible patients, thereby influencing U.S. sales and market share. 

Humira accumulated approximately $21.37 billion (approximately 27.068 trillion won) in global sales last year from which the U.S. market alone accounting for more than 87 percent.

Celltrion plans to expand its share in the adalimumab market by finalizing the ongoing global phase 3 clinical trial of interchangeability between Yuflyma and Humira by the end of the year.  Additionally, the company has entered into an agreement with U.S. biotech Rani Therapeutics to develop oral adalimumab, with the right of first negotiation for global development and commercialization rights if successful.

"There are not many companies in the market with high-concentration biosimilars in various dosage forms such as 80 mg, which will further increase Yuflyma's competitiveness in the U.S. adalimumab market, which is centered on high-concentration formulations," said a Celltrion representative. "We will do our best to make differentiated, high-quality biologics available to more physicians and patients in the U.S.."