Samsung Bioepis has obtained a domestic product license for high-concentration Humira (adalimumab) biosimilars. Competition for prescription with Celltrion, which released high-concentration formulations in Korea and with the original drug, is drawing the industry’s attention.

According to the Ministry of Food and Drug Safety, Samsung Bioepis won approval for two Humira biosimilars – Adalloce Prefilled Syringe Inj. 40mg/0.4mL and Adalloce Pen Inj. 40mg/0/4mL -- on Tuesday.

The products licensed this time are high-concentration Humira biosimilars. They are characterized by the fact that fewer doses can be administered compared to low-concentration items previously licensed in Korea, such as Adalloce Prefilled Syringe Inj. 40mg and Adalloce Pen Inj. 40mg, the ministry said.

Their implications include rheumatoid arthritis, psoriatic arthritis, axial spinal arthritis, Crohn's disease, psoriasis, ulcerative colitis, Becchett enteritis, purulent hives, and nephritis in adults, and Crohn's disease, idiopathic arthritis, and plate dryness in children.

Samsung Bioepis obtained approval for these high-concentration formulations from the U.S. Food and Drug Administration ahead of Korea. With Humira's patent in the U.S. due to expire this year, the company plans to put them to market through Organon in July.

Like the existing low-concentration formulation, it has developed them in prefilled syringe (PFS), and auto-injector (AI) forms that allow self-injections.

Samsung Bioepis explained that it had increased its competitiveness in the domestic prescription market when Humira, the original drug, also expanded treatment options in a situation where high-concentration formulations are predominant.

However, the company did not unveil its target date for the domestic release of these high-concentration products. In the case of existing low-concentration formulations, Samsung Bioepis sells them in partnership with Yuhan Corp. According to market researcher IQVIA, the subscription of low-concentration Adalloce formulations stood at about 2.5 billion won ($1.96 million).

Besides, industry executives watch with interest how the company would compete with Celltrion, which released high-concentration Humira biosimilar, Yuflyma, in the domestic market earlier. Celltrion is supplying the product through Celltrion Pharm.

Celltrion also won a new permit for domestically manufactured Celltrion Yuflyma Pen Inj. 40mg/0.4mL in November. The company said it had decided on domestic manufacturing for smooth production and supply. Existing Yuflyma products were made in Belgium and Hungary.

“Following Europe, the U.S., and Canada, we have won additional approval for high-centration Humira biosimilar,” a Samsung Bioepis official said. “We expect the high centration formulation to meet the prescription needs for diverse administration and dosage.”