Generics and biosimilars in Multiple Sclerosis: understanding efficacy, safety and clinical confidence

Generics and biosimilars are becoming increasingly relevant in Multiple Sclerosis (MS) care as more follow-on treatments enter clinical practice.

In this keynote, Thomas Berger explains how generics and biosimilars differ, how they are evaluated and approved, and why regulatory quality, bioequivalence, immunogenicity and pharmacovigilance are central to confidence in their use.

Key Insights from the Lecture:

• Generics and biosimilars are already established in other areas of neurology, but their use in Multiple Sclerosis remains relatively recent.
• A major concern among both healthcare professionals and patients is whether follow-on treatments provide comparable efficacy and safety to originator products.
• Generic medicines are typically small, chemically synthesized molecules designed to be equivalent to the originator product.Regulatory approval of generics focuses on demonstrating bioequivalence within defined limits.
• Biosimilars are more complex biological products and cannot be identical to their originators because of the natural variability of biological manufacturing.
• Biosimilar approval therefore requires a stepwise demonstration of similarity in pharmaceutical quality, biological characteristics, pharmacokinetics, pharmacodynamics, clinical performance and immunogenicity.
• Immunogenicity is particularly important because biological variation and protein aggregates may influence both safety and treatment efficacy.
• Robust risk-management and pharmacovigilance processes remain important after biosimilar approval.Regulatory standards can differ between regions, and the quality of approval and post-marketing surveillance may affect confidence in follow-on products.
• When appropriate quality standards are met, generics and biosimilars may offer comparable efficacy and safety while reducing treatment costs.
• Lower costs may improve access to treatment and support healthcare system sustainability.However, quality concerns can arise when manufacturing or regulatory standards are not adequately maintained.
• Physicians play an important role in explaining treatment switches and reassuring patients when a generic or biosimilar meets appropriate regulatory requirements.

“Generics and biosimilars in Multiple Sclerosis: understanding efficacy, safety and clinical confidence.”

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About the speaker:

Thomas Berger

Professor of Neurology and Chair of the Dept. of Neurology at the Medical University of Vienna 

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