title: The regulator's perspective: How should new therapies and follow-on products for MS be clinically evaluated in the future?
abstract: Although there is still no cure for multiple sclerosis (MS), the introduction of several innovative drugs with modes of action different from that of the existing drug arsenal and the progress in monitoring disease progression by imaging and using biomarkers are currently causing a knowledge surge. This provides opportunities for improving patient disease management. New therapies are also under development and pose challenges to the regulatory bodies regarding the optimal design of clinical trials with more patient-focused clinical endpoints. Moreover, with the upcoming patent expiry of some of the key first-line MS treatments in Europe, regulatory bodies will also face the challenge of recommending marketing authorisation for generic and abridged versions based on appropriate requirements for demonstrating equality/similarity to the innovator's product.
  
  
  
  The goal of this article is to improve the understanding of the relevant guidance documents of the European Medicines Agency (EMA) on clinical investigation of medicinal products and to highlight the issues that the agency will need to clarify regarding follow-on products of first-line MS treatments.
  
  
  
  Today, it is clear that close collaboration between patients, healthcare professionals, regulatory bodies and industry is crucial for developing new safe and effective drugs, which satisfy the needs of MS patients.
authors.affiliation: Department of Pharmaceutics, Pharmaceutical Sciences, Utrecht Institute for Pharmaceutical Sciences (UIPS), Faculty of Sciences, Utrecht University, Utrecht, The Netherlands D.J.A.Crommelin@uu.nl.
authors.forename: Daan Ja
authors.initials: DJ
authors.lastname: Crommelin
authors.affiliation: President and Head of the Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM), Bonn, Germany.
authors.forename: Karl
authors.initials: K
authors.lastname: Broich
authors.affiliation: European Regulatory Consultant, Chief Scientific Officer of ERA Consulting GmbH, Walsrode, Germany.
authors.forename: Chris
authors.initials: C
authors.lastname: Holloway
authors.affiliation: Managing Director at Ismar Healthcare, Lier, Belgium.
authors.forename: Bianca
authors.initials: B
authors.lastname: Meesen
authors.affiliation: Department of Neurology and Center of Clinical Neuroscience, First Faculty of Medicine, Charles University, Prague, Czech Republic.
authors.forename: Jana
authors.initials: J
authors.lastname: Lizrova Preiningerova
authors.affiliation: Expert Involved in the Development of Recommendations Related to Drug Registrations, Paris, France.
authors.forename: Jean-Louis
authors.initials: JL
authors.lastname: Prugnaud
authors.affiliation: iMed.ULisboa, Faculty of Pharmacy, Universidade de Lisboa, Lisbon, Portugal.
authors.forename: Beatriz
authors.initials: B
authors.lastname: Silva-Lima
mesh_terms: D003299:Cooperative Behavior; D017277:Drug Approval; D015507:Drugs, Investigational / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D007155:Immunologic Factors / Q000009:adverse effects / Q000627:therapeutic use*; D033183:Interdisciplinary Communication; D009103:Multiple Sclerosis / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology / Q000523:psychology; D058996:Quality Improvement; D019984:Quality Indicators, Health Care; D000073597:Stakeholder Participation; D016896:Treatment Outcome
chemical_list: D015507:Drugs, Investigational; D007155:Immunologic Factors
keywords: Biosimilars; follow-on products; generics; multiple sclerosis; non-biological complex drugs (NBCDs); safety