Clinical cases

Real Life Experiences with Biosimilars

This webinar reviewed real-world evidence and clinical experience with biosimilars in Multiple Sclerosis, with a focus on biosimilar natalizumab. It addressed regulatory principles, safety, switching strategies, and practical challenges such as JC virus monitoring in daily clinical practice.

This expert-led webinar explored real-world experience with biosimilars in the treatment of Multiple Sclerosis (MS), with a particular focus on biosimilar natalizumab. Organized by ParadigMS, the session brought together Jelena Drulovic and Tjalf Ziemssen to discuss regulatory principles, clinical evidence, and practical challenges encountered in daily neurological practice.

Professors reviewed the scientific and regulatory framework for biosimilars, emphasizing the concept of “totality of evidence” required for approval, including analytical, functional, pharmacokinetic, pharmacodynamic, efficacy, safety, and immunogenicity data. Particular attention was given to how biosimilars differ from generics and why robust preclinical comparability is central to their development.

Clinical data from MS and other therapeutic areas were examined, highlighting evidence from pivotal trials such as ANTelope, as well as observational and real-world studies. These data support comparable efficacy and safety between biosimilars and reference biologics, including during treatment switching. However, the discussion also addressed real-life nuances, such as patient and physician acceptance, switching strategies, and the importance of structured monitoring.

A major part of the webinar focused on JC virus (JCV) testing and PML risk management in the context of natalizumab biosimilars. Differences between available JCV assays, challenges related to assay concordance, and the clinical implications for treatment decisions were critically discussed. The session concluded with practical recommendations, lessons from other medical fields, and strategies to mitigate nocebo effects through effective communication and shared decision-making.
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