"Our Medicine Is the Same Medicine"... Capturing the 28 Trillion 'Humira' Market by Securing 'Interchangeability'

Celltrion, Samsung Bioepis
Pursuing Clinical Trials for 'Interchangeable' Biosimilar Approval

28 Trillion KRW Global Blockbuster Drug
Intense Battle Ahead for US Market Entry Next Year

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

[Asia Economy Reporter Lee Chun-hee] The competition among companies to dominate the U.S. biosimilar market for the autoimmune disease treatment drug Humira (active ingredient adalimumab), which has a market size of 28 trillion won, is accelerating. To quickly catch up with Humira, some companies are conducting clinical trials for approval of 'interchangeable' biosimilars, while others continue developing the more preferred 'high concentration formulation (HCF).'

On the 23rd, Celltrion announced that it submitted a global Phase 3 clinical trial plan (IND) to European regulatory authorities the day before (local time) to secure interchangeability between its Humira biosimilar 'Yuflyma (CT-P17)' and the original drug. The clinical trial will be conducted in multiple European countries including Estonia and Poland, targeting 366 patients with plaque psoriasis, comparing pharmacokinetics, efficacy, and safety between multiple crossover dosing groups of Yuflyma and Humira and a Humira maintenance dosing group. Celltrion had previously submitted an IND related to this clinical trial to the U.S. Food and Drug Administration (FDA) as well.

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 that ranked first in global sales for nine consecutive years until 2020. Last year, its sales reached $20.7 billion (approximately 28 trillion won), losing the top spot to Pfizer's COVID-19 vaccine 'Comirnaty,' which recorded sales of $36.8 billion (approximately 48 trillion won). However, as the pace of vaccine administration significantly slowed compared to last year, there is a possibility that Humira could regain the number one position from this year onward.

Celltrion's Humira biosimilar (biopharmaceutical generic) 'Yuflyma (40mg/0.4ml)'

Samsung Bioepis also recently began actively recruiting patients for a European Phase 4 clinical trial to evaluate the switching effect of its biosimilar 'Imraldi' (U.S. launch name Hardrima), which was approved in June. Since the product has already been approved in Europe and the U.S., the trial is conducted as an additional 'Phase 4' rather than Phase 3. The study will evaluate interchangeability with Humira in 366 patients with severe chronic psoriasis in Eastern European countries such as the Czech Republic, Poland, and Lithuania.

The reason companies are eager to obtain approval for interchangeable biosimilars is that seven Humira biosimilars have already been approved in the U.S. alone ? Amjevita (Amgen), Cyltezo (Boehringer Ingelheim), Hyrimoz, Hardrima, Abrilada (Pfizer), Hulio (Viatris), and Yusimry (Coherus) ? and Yuflyma is also aiming for FDA approval within this year, intensifying the competition for market share. Especially since all these products aim to launch within next year, the competition for market share is expected to become even fiercer.

The importance of developing interchangeable biosimilars lies in the fact that biosimilars must prove 'similarity' rather than equivalence due to the inherent difficulty of producing biologics identically. Unlike generics (synthetic drug copies), cross-prescription of biosimilars is originally not allowed. However, if a biosimilar is designated as interchangeable, pharmacists can substitute it, and even if the original developer tries to maintain market share by expanding indications, extrapolation to other indications approved for the original drug becomes possible, allowing easier response. However, the FDA has recognized only three interchangeable biosimilars so far: Cyltezo, Semglee (Lantus biosimilar), and Simlandi (Lucentis biosimilar).

Richard Gonzalez, CEO of AbbVie, stated during the Q2 earnings announcement last month, "From next year, Humira (U.S.) sales could be hit by at least 35% and up to 55%," and if interchangeable biosimilars continue to emerge, AbbVie's sales impact could become even more severe.

Samsung Bioepis's Humira biosimilar 'Imraldi' (US product name Hadlima)

In addition, competition around HCF is intensifying. Samsung Bioepis recently received FDA approval for Hardrima's HCF (100 mg/mL). Compared to the existing low concentration formulation (50 mg/mL), the drug dosage is lower, making it more preferred by patients. According to IQVIA, a global pharmaceutical market research firm, 80% of Humira sold in the U.S. last year was HCF.

FDA approval for the high concentration formulation was the first among Hardrima biosimilars, excluding the original drug Humira. Additionally, Sandoz, a subsidiary of Novartis that developed Hyrimoz, applied for FDA approval for HCF last month, and Amgen, which developed Amjevita, is also progressing with development. Celltrion developed Yuflyma as an HCF from the start.

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