Generics, Biosimilars and Follow‐On Non‐Biologic Complex Drugs for Multiple Sclerosis: A Narrative Review of the Regulatory and Clinical Implications for European Neurologists

Authors: Thomas Berger ¹, Markus Zeitlinger ², Veronica Popescu ^3,4, Melinda Magyari ^5,6,7,8, Laura Airas ⁹, Mona Alkhawajah ¹⁰, Maura Pugliatti ¹¹, Magd Zakaria ¹², Carlo Pozzilli ¹³, Jelena Drulovic ¹⁴, Bart Van Wijmeersch ^3,4, Patrick Vermersch ¹⁵, Celia Oreja‐Guevara ^16,17,✉

¹ Department of Neurology and Comprehensive Center for Clinical Neurosciences and Mental Health, Medical University of Vienna, Vienna, Austria,² Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria, ³ University MS Center, Hasselt‐Pelt, Noorderhart Hospital, Belgium, ⁴ Hasselt University, Hasselt, Belgium, ⁵ Danish Multiple Sclerosis Center, Glostrup, Denmark, ⁶ Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark, ⁷ The Danish Multiple Sclerosis Registry, Department of Neurology, Copenhagen University Hospital—Rigshospitalet, Glostrup, Denmark, ⁸ Institute for Clinical Medicine, University of Copenhagen, Copenhagen, Denmark, ⁹ University of Turku, Turku, Finland, ¹⁰ Neuroimmunology Integrated Practice Unit, Neuroscience Center, King Faisal Specialist Hospital and Research Centre, Riyadh, Saudi Arabia, ¹¹ University of Ferrara, Ferrara, Italy, ¹² Ain‐Shams University, Cairo, Egypt, ¹³ University of Roma La Sapienza, Rome, Italy, ¹⁴ University of Belgrade, Belgrade, Serbia, ¹⁵ University of Lille, Inserm U1172, Lille Neuroscience & Cognition Research Centre (LilNCog), CHU Lille, FHU Precise, Lille, France, ¹⁶ Department of Neurology, Hospital Clínico San Carlos, IdISSC, Madrid, Spain, ¹⁷ Department of Medicine, Complutense University of Madrid, Madrid, Spain,

Abstract

Background

Multiple sclerosis (MS) places substantial socioeconomic burden on patients due to its early onset and progressive nature, but healthcare systems are also impacted by the high costs of disease‐modifying treatments (DMTs). The use of generics (for conventional drugs), biosimilars (for biologics) or follow‐on versions of non‐biologic complex drugs (NBCDs) can help to reduce the cost of MS care and improve patient access. This review describes the European regulatory processes for these DMT ‘copies’ and the available data in people with MS.

Methods

A PubMed literature search was undertaken in March 2024, using the terms ‘biosimilar’, ‘generic’, ‘non‐biologic complex drug’, ‘NBCD’ and ‘follow‐on’ in association with ‘multiple sclerosis’.

Results

Our literature search identified three clinical studies with generic treatments for MS (two with generic fingolimod and one with generic dimethyl fumarate), 11 studies with biosimilars (eight with biosimilar interferon formulations, one with natalizumab and two with rituximab biosimilars) and six studies with follow‐on glatiramer acetate. The data showed that the generics, biosimilars and follow‐on NBCDs had similar clinical efficacy and tolerability profiles to the originator drugs, although the quality and quantity of the research varied between DMTs.

Conclusions

In Europe, there are robust regulatory processes for generics, biosimilars and follow‐on NBCDs, in order to ensure that these agents can be considered equally effective and safe as the originator DMT. Physicians caring for people with MS should familiarise themselves with the evidence so that they can have informed conversations about the potential use of these agents.

Keywords:

biosimilars, generics, multiple sclerosis, non‐biologic complex drugs, regulatory approval

© 2025 The Author(s). European Journal of Neurology published by John Wiley & Sons Ltd on behalf of European Academy of Neurology.

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