Pharma firms scramble for slice of lucrative Humira market

A frenzied battle has begun between rival suppliers after the company behind Humira, the world’s top-selling drug for over a decade, lost its exclusive patent protection for the autoimmune treatment.

Samsung Bioepis' Humira biosimilar Hadlima, left, and Celltrion Healthcare's Yuflyma [SAMSUNG BIOEPIS/CELLTRION HEALTHCARE]

A frenzied battle has begun between rival suppliers after the company behind Humira, the world’s top-selling drug for over a decade, lost its exclusive patent protection for the autoimmune treatment.

Developed by Illinois-based AbbVie, Humira, or adalimumab, is used to treat autoimmune diseases including rheumatoid arthritis and Crohn's disease. Humira generated global revenue of $21.2 billion for AbbVie in 2022. Some 88 percent of that revenue, or $18.6 billion, came from the U.S. market.

Samsung Bioepis on Saturday began selling Hadlima, a biosimilar drug of Humira, in the United States with local sales handled by New Jersey-based Organon.

Hadlima is available in both high- and low-concentration formulations in the U.S. market.

The company previously began selling the drug under the brand Imraldi in the European market in 2018, and has so far pulled in $930 million in total revenue.

Celltrion Healthcare also released Yuflyma, a biosimilar of Humira, in the U.S. market on Sunday.

Yuflyma’s wholesale price is about 5 percent cheaper than the original Humira drug at $6,576 per two doses, according to the company. Yuflyma is already on sale in various European countries. It was the world’s first high-concentration Humira biosimilar approved by the European Medicines Agency.

Higher concentrations are generally favored by the market for their convenience as they allow patients to take fewer doses and may cause less discomfort. High-concentration formulations account for some 86 percent of the U.S. adalimumab market.

As AbbVie lost its patent protection on the billion-dollar-worth blockbuster drug in January in the United States, global biopharmaceutical manufacturers such as Pfizer and Germany’s Boehringer Ingelheim are tapping into the multibillion-dollar market with their own version of copycat drugs.

California-based Amgen introduced Amjevita, the first Humira biosimilar in the U.S. market, on Jan. 31 as a low-concentration formulation.

Biosimilars, according to the U.S. Food and Drug Administration (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 do cost less.

BY SHIN HA-NEE [shin.hanee@joongang.co.kr]