The 2025 European Academy of Dermatology and Venereology (2025 EADV), the largest dermatology conference in Europe, opened on the 17th (local time) in Paris, France. Running through the 20th, EADV 2025 is a venue where more than 16,000 medical professionals in dermatology and venereology from over 120 countries share the latest clinical trials and drug development trends.
Among domestic corporations, Celltrion took part through a corporate booth and symposiums to showcase the competitiveness of biosimilars (biologic drug copies). Europe is pursuing policies that actively introduce biosimilars. As a leading regulator of biosimilars, it is also a market where competition for market share among global pharmaceutical and biotech companies is fierce.
On the first day of the conference, Celltrion unveiled for the first time in a poster the results of a phase 1 clinical trial demonstrating that CT-P55 (ingredient secukinumab), which is being developed as a biosimilar for autoimmune disease treatment, is equivalent in efficacy and safe compared with the original drug. Autoimmune diseases, in which the immune system mistakenly attacks healthy cells as pathogens, cause chronic skin inflammation and rashes, making them an active area of research and discussion in the dermatology field.
The original drug of CT-P55 is Cosentyx by the Swiss pharmaceutical company Novartis. In January 2015, it received its first approval from the U.S. Food and Drug Administration (FDA) as a treatment for plaque psoriasis, and its indications (treatment areas) have expanded to psoriatic arthritis, axial spondyloarthritis, hidradenitis suppurativa, pediatric plaque psoriasis, juvenile idiopathic arthritis, and active ankylosing spondylitis. Last year, Cosentyx's global sales rose 23% from the previous year to $6.141 billion (about 8.47 trillion won).
Secukinumab, the active ingredient in both Cosentyx and CT-P55, selectively neutralizes interleukin (IL)-17A, an immune signaling molecule, to suppress excessive immune responses. When interleukin-17A is overexpressed in certain cells, it promotes inflammatory responses and leads to rheumatoid arthritis, asthma, multiple sclerosis, psoriasis, and transplant rejection.
The key to biosimilar development is to verify whether it produces the same effect as the original drug. Celltrion conducted a clinical trial by randomly assigning 172 healthy adults in a 1:1:1 ratio to receive a single 150 mg subcutaneous injection of one of CT-P55, Europe-approved secukinumab, or U.S.-approved secukinumab. Celltrion said that through a 22-week evaluation it demonstrated bioequivalence to the original drug and confirmed that safety and immunogenicity did not differ from the original.
Among the attendees viewing the poster containing the clinical results for CT-P55 were Novartis researchers who hold the original drug. A Novartis employee said, "I watched with interest because (CT-P55) is a competing drug to secukinumab (Cosentyx)."
Celltrion is also conducting a phase 3 clinical trial of CT-P55 in 375 patients with severe plaque psoriasis. Plaque psoriasis is also one type of autoimmune disease, in which thick, red skin rashes covered with silvery scales appear across the body.
Biosimilars usually skip phase 2 trials, which test dosing regimens, and proceed with phases 1 and 3. That is because the dosing regimen is the same as the original drug. Phase 1 evaluates in healthy individuals whether the drug's effect is properly absorbed and metabolized in the body to demonstrate equivalence to the original, and phase 3 confirms therapeutic efficacy and safety in patients.
Among domestic corporations developing a Cosentyx biosimilar, Celltrion is the only one. Celltrion has focused on strengthening its competitiveness in autoimmune disease treatments. It previously launched Remsima intravenous injection (IV) and subcutaneous injection (SC), Yuflyma, and Aptozyme as autoimmune disease treatments. With more than 100 types of autoimmune diseases, the market is also large. Celltrion said it will expand its lineup of new products to further increase its global market share.
Celltrion plans to launch Omriclo (ingredient omalizumab), first developed as a biosimilar to the allergy treatment Xolair, in Europe within this year. At this conference, it will present global phase 3 clinical data for Omriclo covering a total of 40 weeks, including post-treatment follow-up.