Category: Publications 24 August 2022
How to use biosimilars and generic NBCDs as DMTs for Multiple Sclerosis?
Co-authored by Christian Wolf:
Use of follow-on disease-modifying treatments for multiple sclerosis: Consensus recommendations.
Wallace J Brownlee, Christian Wolf, Hans-Peter Hartung, Theo Dingermann, Nadia Anshasi, Richard AC Clark, Maria Trojano, Krzysztof Selmaj, Bernard MJ Uitdehaag, Carmen Tur, Jens Wuerfel, Gabriele Dallmann, Julian Witte, Martina Sintzel, Olga Bobrovnikova, and Jeffrey A Cohen.
Mult Scler J. 2022; 135245852211162. (abstract).
As patents for multiple sclerosis (MS) therapies expire, follow-on disease-modifying treatments (FO-DMTs) become available at reduced cost. Concerns exist that cheaper FO-DMTs are used simply to reduce healthcare costs. However, the well-being of people with MS should take priority.
To identify best practices for FO-DMT development and use by agreeing on principles and consensus statements through appraisal of published evidence.
Following a systematic review, we formulated five overarching principles and 13 consensus statements. Principles and statements were voted on by a multidisciplinary panel from 17 European countries, Argentina, Canada and the United States.
All principles and statements were endorsed by >80% of panellists. In brief, FO-DMTs approved within highly regulated areas can be considered effective and safe as their reference products; FO-DMTs can be evaluated case by case and do not always require Phase III trials; long-term pharmacovigilance and transparency are needed; there is lack of evidence for multiple- and cross-switching among FO-DMTs; and education is needed to address remaining concerns.
Published data support the use of FO-DMTs in MS. The consensus may aid shared decision-making. While our consensus focused on Europe, the results may contribute to enhanced quality standards for FO-DMTs use elsewhere.