'D-38' US Humira Biosimilar War, Celltrion Also Joins the Battle

$25 Trillion US Market Opens Wide from July
Celltrion's 'Uplima' Achieves FDA Approval

Key Factor: 'Concentration'... High Concentration Preferred
Uplima Developed in High Concentration with Citrate Removed

With the US biosimilar (biopharmaceutical) market for Humira (active ingredient adalimumab), worth approximately 25 trillion won, opening this July, a fierce battle for market share is expected. Competition is set to intensify as Celltrion's biosimilar 'Yuflyma (CT-P17)' successfully secured last-minute approval just before the start of the competition.

Incheon Songdo Celltrion Plant 2 Overview. / Incheon - Photo by Hyunmin Kim kimhyun81@

Celltrion announced on the 24th that Yuflyma received approval from the US Food and Drug Administration (FDA) on the 23rd (local time). This allows the company to meet the scheduled US market launch date of July 1. In terms of indications, Yuflyma secured eight major indications among those held by Humira, including rheumatoid arthritis, psoriasis, and inflammatory bowel diseases (ulcerative colitis and Crohn's disease), establishing a foothold for future market share competition.

Humira is a global blockbuster with sales reaching $21.237 billion (approximately 28 trillion won) last year. Although it lost its top spot to Pfizer's COVID-19 vaccine 'Comirnaty' during the COVID-19 pandemic, it had maintained the world's number one sales position for over a decade. However, with the successive launch of biosimilars, its market share has sharply declined in Europe and other regions. On the other hand, in the US market, where the biosimilar market has not yet been established, sales actually increased to $18.619 billion (approximately 24.5566 trillion won), maintaining a growth rate of 7.4% compared to the previous year. However, as biosimilar developers who have reached patent agreements with AbbVie are expected to launch competitively starting this year, US sales are also projected to decline sharply.

The success of the biosimilar battle starting in July is expected to hinge on concentration. Humira is available in a low concentration formulation of 50 mg/mL and a high concentration formulation (HCF) of 100 mg/mL, which reduces the drug dosage by half. While there is still demand for the low concentration product, preference for the HCF is higher. According to pharmaceutical market research firms Symphony Health and IQVIA, 85% of adalimumab sold in the US last year was the HCF formulation.

Currently, the adalimumab HCF products approved in the US include four: the original, Yuflyma, Samsung Bioepis's 'Hadlima', and Sandoz's 'Hyrimoz'. This market situation also explains why Amgen, which launched 'Amjevita' as the first biosimilar in January, has yet to achieve notable results despite aiming to capture market share. Amgen has only completed development of the low concentration formulation. The HCF is currently in clinical trials, with plans to launch it next year. According to Samsung Securities, Amjevita was prescribed only 662 times in the US last month, holding a market share of about 0.3%. This was an increase of just 76 prescriptions compared to 586 the previous month. July, when HCF biosimilars will be released in earnest, is considered the starting point of the real competition.

In response, Celltrion developed Yuflyma as an HCF (40 mg/0.4 mL) formulation with citrate removed to reduce pain concerns. At the same time, global Phase 3 clinical trials are underway in the US and Europe to secure interchangeability with the original product, aiming to enhance competitiveness. Sales will be handled by Celltrion Healthcare, which is responsible for overseas marketing and distribution of Celltrion products. As the company is recently establishing a direct sales network in the global market, further achievements through this channel are anticipated.

A Celltrion representative said, "With this approval, Yuflyma has secured an opportunity to establish a leading position as an HCF biosimilar in the largest adalimumab market, the US. We will do our best to settle early in the US market with differentiated competitiveness through consultations with Celltrion Healthcare."