ReviewEuropean journal of neurology2025
Generics, Biosimilars and Follow-On Non-Biologic Complex Drugs for Multiple Sclerosis: A Narrative Review of the Regulatory and Clinical Implications for European Neurologists.
Review in European journal of neurology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
2 citing papers in PubMed, 1 synthesis or guideline pooled it.
- An updated review of the economic burden of multiple sclerosis: direct and indirect costs.Frontiers in immunology · 2026Pooled it
- Unpacking the anti-fibrotic arsenal: molecular mechanisms and therapeutic translation of MSC-derived exosomes in pulmonary fibrosis.Frontiers in immunology · 2025Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors.
Funding
Abstract
backgroundMultiple 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.
methodsA 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'.
resultsOur 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.
conclusionsIn 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.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.