Medical experts met at the European Academy of Dermatology and Venereology (EADV 2025) in Paris, France, from the 17th to the 20th (local time) said they expect biosimilars (copies of biologic drugs) to dramatically improve access to treatment for autoimmune diseases such as chronic spontaneous urticaria (CSU).
Martin Metz, a professor of dermatology at Charité – Universitätsmedizin Berlin in Germany, and Fernando de Mora, a professor at the School of Pharmacy at the Autonomous University of Barcelona in Spain, gave a presentation on the theme "Use and understanding of biosimilars in chronic spontaneous urticaria" at a symposium held on the afternoon of 18th.
The symposium proceeded with Celltrion presenting the results of its phase 3 clinical trial of Omlyclo (ingredient name omalizumab), followed by a discussion among experts on how it could contribute to patient care. Omlyclo is a biosimilar of Xolair, an allergy treatment developed by Switzerland's Novartis.
Professor Metz said, "Unlike generics (copies of synthetic drugs), biosimilars maintain a complex antibody structure while showing efficacy equivalent to the original," adding, "The emergence of an omalizumab biosimilar provides a new option in CSU treatment, and the key is expanding patient access."
Regarding the clinical trial results of Omlyclo, he said, "What matters is that it demonstrated a high level of efficacy and safety, as well as equivalence with the original," evaluating it as "a meaningful milestone in the CSU field, which lacked biosimilars for more than 10 years."
Professor Metz said, "It is meaningful that patient options have increased as new drugs such as dupilumab and remibrutinib have entered CSU treatment alongside omalizumab," while also assessing, "Omalizumab still has strong competitiveness compared with new drugs because its predictability and stability come from more than 10 years of accumulated treatment experience."
Omalizumab is the ingredient name for Xolair and Omlyclo. Dupilumab is the ingredient of Dupixent, a CSU treatment developed by France's Sanofi and the United States' Regeneron, and remibrutinib is the ingredient name of Novartis' oral Bruton tyrosine kinase (BTK) inhibitor. Although new drugs with different targets and treatment mechanisms have been introduced following the original drug Xolair, the point is that omalizumab-containing treatments still have strengths compared with the new drugs.
Professor Metz said, "Biosimilars do not shake the entire treatment paradigm, but their social contribution in enabling more patients to benefit from treatment is significant," adding, "Biosimilars allow more patients to receive care within existing healthcare systems and can ease the financial burden on national healthcare systems."
Professor de Mora highly assessed the significance that Celltrion's first antibody biosimilar, Remsima, had on the entire industry. He said, "Antibodies, being proteins, have complex structures, so biosimilar development was considered impossible, but Celltrion proved it was possible," adding, "It paved the way for the development of more than 70 antibody biosimilars."
Professor de Mora argued that biosimilars are not merely copycat drugs but a driver of innovation. He said, "Through new delivery methods such as the Remsima SC (subcutaneous) formulation, we can improve patient convenience," evaluating that "such efforts even spur original pharmaceutical companies, leading to innovation across the industry."
He also mentioned regulatory changes. Professor de Mora said, "Over more than 20 years of experience, the fact that originals and biosimilars have the same efficacy and safety has been demonstrated repeatedly." He added, "The European Medicines Agency (EMA) is moving toward reducing clinical trial requirements for biosimilars and strengthening laboratory analyses," and said, "Once equivalence is secured, substitution is also possible."
As for future research directions, he pointed to the use of artificial intelligence (AI) and big data. Professor de Mora said, "If we train AI on clinical and real-world prescribing data, we can determine which dose for which patient is most effective and safe," forecasting that "it will contribute not only to equivalent drugs but also to the development of 'bio-betters (improved biologics).'"