title: The challenge of follow-on biologics for treatment of multiple sclerosis.
abstract: 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.
authors.affiliation: Scientific and Clinical Review Associates LLC, PO Box 342, Salisbury, CT 06068, USA. scra.llc@earthlink.net
authors.forename: S C
authors.initials: SC
authors.lastname: Reingold
authors.forename: J P
authors.initials: JP
authors.lastname: Steiner
authors.forename: C H
authors.initials: CH
authors.lastname: Polman
authors.forename: J A
authors.initials: JA
authors.lastname: Cohen
authors.forename: M S
authors.initials: MS
authors.lastname: Freedman
authors.forename: L
authors.initials: L
authors.lastname: Kappos
authors.forename: A J
authors.initials: AJ
authors.lastname: Thompson
authors.forename: J S
authors.initials: JS
authors.lastname: Wolinsky
mesh_terms: D001688:Biological Products / Q000191:economics / Q000592:standards* / Q000627:therapeutic use*; D017277:Drug Approval / Q000379:methods; D015195:Drug Design; D004345:Drug Industry / Q000191:economics / Q000592:standards; D006801:Humans; D007155:Immunologic Factors / Q000191:economics / Q000493:pharmacokinetics / Q000627:therapeutic use; D016899:Interferon-beta / Q000191:economics / Q000493:pharmacokinetics / Q000627:therapeutic use; D008970:Molecular Weight; D009103:Multiple Sclerosis / Q000628:therapy*; D013810:Therapeutic Equivalency
chemical_list: D001688:Biological Products; D007155:Immunologic Factors; D016899:Interferon-beta