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The challenge of follow-on biologics for treatment of multiple sclerosis

From Scientific and Clinical Review Associates, LLC (S.C.R.), Salisbury CT, and New York, NY; Department of Neurology (J.P.S.), Johns Hopkins University, Baltimore, MD; Department of Neurology (C.H.P.), Free University Medical Center, Amsterdam, The Netherlands; The Mellen Center for Multiple Sclerosis Treatment and Research (J.A.C.), Neurological Institute, Cleveland Clinic, OH; Multiple Sclerosis Research Unit (M.S.F.), The Ottawa Hospital-General Campus, University of Ottawa, Ontario, Canada; Neurology and Department of Medicine (L.K.), University Hospital, University of Basel, Switzerland; UCL Institute of Neurology (A.J.T.), Queen Square, London, UK; and Department of Neurology (J.S.W.), University of Texas Health Science Center, Houston, TX.

Address correspondence and reprint requests to Dr. Stephen C. Reingold, Scientific and Clinical Review Associates LLC, PO Box 342, Salisbury, CT 06068 scra.llc{at}earthlink.net

Intellectual property protections for biologic medicinals for multiple sclerosis (MS) are beginning to expire, opening the possibility of development, regulatory approval, and marketing of so-called follow-on biologics, biosimilars, or subsequent entry biologics that might be offered at lower price to consumers and third-party payers, as has been the case for generic drugs. Determining the comparability of a follow-on biologic to its innovator product is more difficult than for small-molecule drugs because of the greater complexity of biologics and the possibility that manufacturing differences can introduce differences in biologic activity and immunogenicity that could result in unpredictable differences in safety or efficacy. We provide a perspective on issues surrounding development, regulatory approval, and potential use of follow-on biologics, with an emphasis on disease-modifying agents for MS.

Abbreviations: CHMP = Committee for Medicinal Products for Human Use; EMEA = European Medicines Agency; FDA = Food and Drug Administration; MS = multiple sclerosis.

Disclosure: Author disclosures are provided at the end of the article.

Received February 8, 2009. Accepted in final form May 15, 2009.

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