Samsung Bioepis Releases Real-World Observational Data on 'Humira' Biosimilar

Humira Biosimilar 'SB5'

Presented at EADV Conference in Milan, Italy
Real-world Prescription Data Since 2018 European Launch
72% Maintained SB5 Prescription for Over 3 Years

Competition Heats Up Ahead of US Market Entry Next Year

Samsung Bioepis's autoimmune disease treatment 'Humira (active ingredient Adalimumab)' biosimilar 'Imraldi (SB5's European launch name)'

[Asia Economy Reporter Lee Chun-hee] The competition to develop biosimilars of AbbVie's $28 trillion autoimmune disease treatment 'Humira' (generic name adalimumab) is intensifying. Ahead of the opening of the U.S. market next year, a battle is underway to prove efficacy and safety by releasing real-world data (RWD).

Samsung Bioepis announced on the 7th that it will present three-year follow-up data of 'SB5,' a Humira biosimilar under development, at the European Academy of Dermatology and Venereology (EADV) Congress. Marking its 31st year, EADV is a prestigious European dermatology society. The event will be held simultaneously in Milan, Italy, and online over four days from the 7th to the 10th.

Samsung Bioepis plans to release an abstract of the "three-year follow-up study results after SB5 prescription for moderate-to-severe psoriasis patients observed in the UK registry 'British Association of Dermatologists Biologic and Immunomodulators Register (BADBIR) study'." BADBIR is a registry in the UK and Ireland that evaluates the long-term safety of biologic treatments for psoriasis. Samsung Bioepis has participated in the study since May 2016.

According to the abstract, the follow-up study was conducted on 1,059 psoriasis patients prescribed SB5 registered in BADBIR from June 2019 to August last year. The results showed that the treatment continuation rate over three years was 72.1%. The cumulative continuation rates for the first, second, and third years were 79.7%, 73.5%, and 72.1%, respectively.

Jin-ah Jung, head of Samsung Bioepis Medical Affairs, said, “Long-term RWD demonstrating the efficacy and safety of adalimumab biosimilars prescribed for psoriasis is rare, and through this study, we have proven that SB5 possesses safety and efficacy comparable to the original drug.”

AbbVie's autoimmune disease treatment 'Humira (active ingredient Adalimumab)'

Humira, developed by AbbVie, is a treatment for immune-mediated diseases such as rheumatoid arthritis, Crohn's disease, and plaque psoriasis. It was a blockbuster drug ranked number one in global sales for nine consecutive years until 2020. Last year, it recorded sales of $20.7 billion (approximately 28.71 trillion KRW), losing its top spot to Pfizer's COVID-19 vaccine 'Comirnaty,' which earned $36.8 billion (about 51 trillion KRW), but it is expected to regain the number one position next year.

While biosimilar competition has already intensified with SB5 marketed under the product name 'Imraldi' since 2018 in Korea, Europe, and other regions, Humira still dominates the U.S. market. Although the substance patent expired in 2016, AbbVie delayed the launch through patent disputes, and most biosimilars have agreed to launch next year. According to FDA standards, seven products have been approved: Amjevita (Amgen), Cyltezo (Boehringer Ingelheim), Hyrimoz (Sandoz), Hadlima (the U.S. launch name of SB5), Avrilada (Pfizer), Hulio (Viatris), and Yusimry (Coherus), all preparing for launch next year. Celltrion is also undergoing approval procedures aiming to launch 'Yuflyma (CT-P17)' in July next year.

Samsung Bioepis is accelerating preparations for the U.S. market launch, recently receiving FDA approval for Hadlima's high-concentration formulation (HCF, 100 mg/mL). This formulation requires a lower drug dose than the existing low-concentration formulation (50 mg/mL), making it more preferred by patients.

FDA approval for the high-concentration formulation is known to be the first among biosimilars, excluding the original drug Humira. This has established a foothold for preempting the U.S. market opening next year. Consequently, other biosimilar developers are also developing HCF formulations. Sandoz, a Novartis subsidiary that developed Hyrimoz, applied for FDA HCF approval in July, and Amgen, which developed Amjevita, is also developing HCF. Celltrion developed Yuflyma's basic formulation as HCF from the start.

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