The European Academy of Dermatology and Venereology (EADV) 2025, Europe's largest dermatology conference, was held from the 17th to the 20th (local time) at the Paris Convention Center in France. This year, about 16,000 people from more than 120 countries attended.
At this year's conference, global pharmaceutical and biotech corporations and functional cosmetics corporations participated in large numbers and operated corporate exhibition booths. Korea-based Celltrion was the only biosimilar (biopharmaceutical copy drug) corporation to open a booth and also hosted a symposium.
Upon entering Celltrion's 91㎡ corporate exhibition booth, the first thing that stood out was the phrase on monitors installed throughout the space: "The 1 Omalizumab Biosimilar, Omlyclo is now available!"
Omlyclo, developed by Celltrion, is a biosimilar of Xolair (ingredient name omalizumab), a treatment widely used for asthma and chronic spontaneous urticaria, and secured "first-mover" status by obtaining the first approvals in Europe and the United States.
A British specialist who visited the Celltrion booth said, "I already have experience prescribing Celltrion's autoimmune disease treatment Yuflyma to patients," and asked, "From when can our hospital use omalizumab?" showing anticipation.
◇ "Accelerating the switch to Omlyclo with first-mover status"
Xolair, the original drug co-developed by U.S.-based Genentech and Switzerland-based Novartis, is a medication that controls allergy symptoms caused by immunoglobulin E (IgE) antibodies. It received approval from the U.S. Food and Drug Administration (FDA) in Jun. 2003 as an asthma treatment and has continued to expand treatable indications. In the United States last year, it was additionally approved for a food allergy indication. Last year's global sales were about 6.4992 trillion won.
Omalizumab, the active ingredient in Xolair and Omlyclo, inhibits the binding of IgE antibodies to mast cells, thereby suppressing inflammatory responses. Xolair's European patent expired on the 8th, and in the United States its patent is set to expire in Nov. Omlyclo's arrival signals a crack in Xolair's solo run.
Celltrion plans to begin in Norway and sequentially launch Omlyclo in European countries within the year. The company's goal is to have more than half of all patients in Europe use Omlyclo. Celltrion highlighted a lower price than the original drug and storage advantages as Omlyclo's competitive edges.
The company said Omlyclo has been developed with a shelf life at room temperature and under refrigeration that is five days and six months longer, respectively, than Xolair. It also removed the latex (rubber) component found in the original drug so that patients with latex allergies can use it.
Ha Tae-hoon, head of Celltrion's Europe division, said, "As Omlyclo enters the global market as a first mover, we will do our best to provide treatment benefits to more patients and to increase market share based on Celltrion's research and development capabilities and direct sales infrastructure."
◇ "Trust that began with Remsima, expanding with Omlyclo"
Salim Benkhalifa, medical director at Celltrion's French subsidiary, whom we met at the conference, said, "A biosimilar is not just a substitute for the original drug; it is a product that performs a social mission by easing the burden of medical expenses and enabling more patients to receive early treatment," adding, "As the first omalizumab biosimilar, Omlyclo will contribute to reducing social expenses and expanding patient access."
He said, "Patients with severe asthma account for 5% of all asthma patients, but they account for more than 50% of medical expenses," explaining, "When a biosimilar is launched, drug prices fall, which has a large effect on saving medical finances." He also said, "Omlyclo has obtained approval for both the auto-injector (AI) and prefilled syringe formulations, enabling us to meet the diverse needs of both physicians and patients."
Director Benkhalifa cited quality, swift responsiveness, and a direct sales model as reasons Celltrion's products have rapidly increased market share in Europe. He said, "In Europe, drug supply shortages or interruptions are very sensitive issues, but Celltrion has established a direct sales model, allowing it to communicate directly with medical staff without going through intermediaries and to manage inventory and supply, which makes on-site response faster."
Director Benkhalifa said, "Based on its experience with Remsima, an autoimmune disease treatment that became the world's first antibody biosimilar to receive sales approval in Europe, Celltrion has built the capability to directly control the entire process from development and clinical trials to manufacturing and distribution," adding, "This expertise is the key that is earning trust from medical professionals and partners."