A Comprehensive Review on Copemyl®

Pierluigi Navarra, Pietro Annovazzi, Antonio Bertolotto, Vincenzo Brescia Morra, Claudio Gasperini, Enrico Montanari, Francesco Patti, Maria Pia Sormani, Angelo Ghezzi

Risultato della ricerca: Contributo in rivistaArticolo in rivista

5 Citazioni (Scopus)

Abstract

Economic sustainability is of paramount importance in the rapidly evolving therapeutic scenario of multiple sclerosis (MS). Glatiramoids are a class of drugs whose forefather, glatiramer acetate, has been used as a disease modifying drug (DMD) in patients with MS for over 20 years. Its patent expired in 2015; new versions of such drug are nowadays available on the market, potentially contributing to lowering prices and enhancing a better allocation of economic resources. In this review, we analyze the recommendations underlying the approval of both generic drugs and biosimilars by regulatory authorities, and we provide methodological tools to contextualize the design of studies on these new classes of drugs. We examine in more detail the preclinical and clinical data of Copemyl®, a new member of the glatiramoid class, focusing on its biological and immunological properties and illustrating randomized controlled trials that led to its authorization.
Lingua originaleEnglish
pagine (da-a)161-173
Numero di pagine13
RivistaNeurology and Therapy
Volume6
DOI
Stato di pubblicazionePubblicato - 2017

Keywords

  • Bioequivalence
  • Copemyl®
  • Glatiramer acetate
  • Glatiramoid
  • Multiple sclerosis
  • Neurology
  • Neurology (clinical)
  • Non-biological complex drugs

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