Real-Life Experiences with biosimilars 

Key takeaways

• Generics and biosimilars are increasingly relevant in Multiple Sclerosis (MS) as healthcare systems seek cost containment without compromising clinical outcomes.
• Biosimilars are not identical copies, but are rigorously evaluated to demonstrate high similarity to reference biologics in structure, efficacy, safety, and immunogenicity through the EMA/FDA “totality of evidence” framework.
• Clinical trials and real-world evidence consistently show comparable efficacy and safety between originator biologics and biosimilars used in MS, including interferon beta, rituximab (off-label), and natalizumab.
• Switching from originator to biosimilar therapies is generally safe and effective when supported by structured monitoring, patient education, and pharmacovigilance.
• Biosimilar natalizumab has demonstrated equivalent clinical and MRI outcomes to reference natalizumab in phase III trials and has been approved by the EMA, expanding access to high-efficacy treatment options.
• Trust, communication, and diagnostic reliability are critical determinants of successful biosimilar adoption, with nocebo effects and assay variability representing key real-world challenges.
• Experiences from other therapeutic areas (oncology, rheumatology, gastroenterology) show that education, transparency, and robust registries are essential to sustain long-term biosimilar integration.

The presentation

The experts biographies

Jelena Drulovic

Professor of Neurology at the Faculty of Medicine, University of Belgrade

Tjalf Ziemssen

Professor of Clinical Neuroscience at University Clinic Carl-Gustav Carus in Dresden

Sponsor

This educational material is the presentation of a recorded webinar. The webinar was sponsored by Sandoz. Sandoz was not involved in the elaboration of the presentations.

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