Samba Epis launches Humira biosimilar 'Hadlima' in the US... Entering the 23 trillion won market

Simultaneous Securing of Low- and High-Concentration Formulations
Supply to 24 Global Markets Including Europe

Samsung Bioepis announced on the 3rd that it launched the Humira biosimilar 'Hadlima (SB5; generic name adalimumab)' in the United States on the 1st (local time) through its partner Organon.

Hardrima pre-filled pen (pre-filled pen·PFP).
[Photo by Samsung Bioepis]

Hadlima is a treatment for autoimmune diseases such as rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, and plaque psoriasis.

Hadlima was launched in the U.S. market in two formulations: low concentration (50 mg/mL) and high concentration (50 mg/mL). Marketing and sales activities by partner Organon began locally on the 1st of this month. Hadlima is packaged in units of two and has been approved in both pre-filled pen (PFP) and pre-filled syringe (PFS) forms.

Samsung Bioepis obtained U.S. sales approval for the low concentration and high concentration Hadlima in 2019 and 2022, respectively, and has been supplying patients in Europe (under the product name Imraldi) since October 2018. Currently, SB5 is supplied in 24 markets worldwide, including the European market, and clinical prescription data from more than 5,100 patients across rheumatoid, dermatologic, and gastrointestinal diseases have been collected.

Go Han-seung, CEO of Samsung Bioepis, said, "Over the past four years, Samsung Bioepis has supplied approximately 6.8 million SB5 units outside the U.S. market through strict quality control and supply chain management, and we are pleased to now provide Hadlima to patients in the U.S." He added, "We hope Hadlima will expand treatment accessibility for patients suffering from autoimmune diseases in the United States."

Meanwhile, Humira recorded annual product sales of $21.2 billion (approximately 27 trillion KRW) last year, with product sales in the U.S. market accounting for 88% of total sales, reaching 23 trillion KRW.

This content was produced with the assistance of AI translation services.