A recent analysis suggests that biosimilars are no longer merely alternatives but are rapidly becoming the standard of care in clinical settings. Academic experts unanimously agree that clinical data have dispelled concerns over structural differences, while the impact of cost reduction and improved accessibility is driving tangible changes in treatment patterns.
On September 18th, during a symposium hosted by Celltrion (068270) at the European Academy of Dermatology and Venereology (EADV) conference, leading clinical and regulatory experts from Spain, the UK, and Germany took the stage to discuss the past, present, and future challenges of biosimilars.
Professor Fernando de Mora from the Autonomous University of Barcelona emphasized that although biosimilars cannot be structurally identical to the original, what truly matters is their clinical equivalence.
He stated that any differences must be proven clinically insignificant through quality analysis, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity assessments. De Mora clarified that extrapolation is justified only when the mechanisms, exposure, and immunogenicity evidence are aligned.
He also noted that with the accumulation of switching studies and real-world evidence, confidence in safety and efficacy is growing. De Mora added that future key challenges include educating patients and healthcare professionals, as well as ensuring consistent traceability.
Professor Peter from Guy’s and St Thomas’ Hospital in London shared his experience with inflammatory bowel disease (IBD), explaining that randomized controlled trials and government-led switching studies have confirmed no differences in efficacy, safety, or immunogenicity.
He pointed out that cost savings from biosimilars have enabled early treatment, dose adjustments, and combination strategies, potentially increasing rates of steroid-free remission among patients.
Peter particularly emphasized that innovations in formulations, such as subcutaneous administration, have improved patient convenience and adherence. “When we transparently explain treatment changes to patients, acceptance increases significantly,” he added. “Cost savings enhance access to new drugs, directly improving patients’ quality of life.”
Professor Martin Metz, who chaired the session, stated that initial skepticism has been addressed through systematic comparative data, standardized clinical designs, and robust pharmacovigilance.
He noted, “A virtuous cycle has emerged in which evidence leads to recommendations that then disseminate into real-world clinical practice.” Metz emphasized that new challenges—such as device and digital tracking, patient-reported outcomes (PROs), and clear substitution policies—are now crucial.
He concluded that biosimilars have already driven increased accessibility and shifted treatment paradigms, stressing that ongoing monitoring and communication among stakeholders remain key challenges.