Celltrion's biosimilar Yuflyma approved for sale in U.S.

Industry

Celltrion's biosimilar Yuflyma approved for sale in U.S.

Published: 24 May. 2023, 14:55 Updated: 24 May. 2023, 18:26

Celltrion's Yuflyma [CELLTRION]

Yuflyma, a Celltrion biosimilar of the autoimmune diseases drug Humira, was approved for sale in the United States.

With permission from the U.S. Food and Drug Administration (FDA), Celltrion can now sell the drug in the U.S. market starting in July.

Humira, or adalimumab, is used to treat autoimmune diseases including rheumatoid arthritis and Crohn's disease. AbbVie, Humira's Illinois-based developer, held an exclusive grip on the market for two decades, earning nearly $200 billion from sales of the drug during that period.

It had been the world’s best-selling for a decade until 2020, when it lost its throne to the Pfizer Covid-19 vaccine. It generated global revenue of $21.2 billion last year, with around 87 percent of that revenue coming from the U.S. market.

Yuflyma's competitiveness stands out as it was approved as high-concentration, which is generally favored by the market for its convenience as it allows patients to take lower doses and can cause less discomfort. High formulations account for some 85 percent of the U.S. adalimumab market.

Yuflyma is the world’s second high-concentration Humira biosimilar approved by the U.S. market right after Samsung Bioepis' Hadlima. California-based Amgen introduced Amjevita, the first Humira biosimilar in the U.S. market, on Jan. 31 as a low-concentration formulation.

Yuflyma also has no citrate, which can cause pain, Celltrion said.

Celltrion is also undergoing Phase 3 clinical trials of Yuflyma to be recognized as interchangeable with Humira. An “interchangeable label” from the FDA allows pharmacists to choose the biosimilar over Humira when filling prescriptions, rather than requiring the prescribing doctor to specify it.

Biosimilars, according to the FDA, are biological products that are approved based on proof that they are highly similar to other FDA-approved products. The drugs have no clinically meaningful differences in terms of safety or efficacy from the reference product, but they cost less.

BY SARAH CHEA [chea.sarah@joongang.co.kr]