title: Biosimilars and market access: a question of comparability and costs?
abstract: This article discusses specific issues related to the market access of biosimilars. Biopharmaceuticals are complex molecules produced by living cells. Copies of these medicines, called biosimilars, are not identical to their reference medicine and therefore specific regulatory requirements apply. When considering the use of biosimilars, the question of the degree of comparability between a biosimilar and the reference biopharmaceutical needs to be considered for registration, pricing and reimbursement purposes in addition to the cost issue. To date, many key concepts (like clinically meaningful differences) remain undefined and the question of the degree of comparability is not yet resolved.
authors.affiliation: Research Centre for Pharmaceutical Care and Pharmaco-economics, Faculty of Pharmaceutical Sciences, Katholieke Universiteit Leuven, Onderwijs en Navorsing 2, Herestraat 49, P.O. Box 521, 3000 Leuven, Belgium. steven.simoens@pharm.kuleuven.be
authors.forename: Steven
authors.initials: S
authors.lastname: Simoens
authors.forename: Gilbert
authors.initials: G
authors.lastname: Verbeken
authors.forename: Isabelle
authors.initials: I
authors.lastname: Huys
mesh_terms: D059451:Biosimilar Pharmaceuticals / Q000627:therapeutic use*; D003362:Cost-Benefit Analysis; D055808:Drug Discovery / Q000331:legislation & jurisprudence; D005060:Europe; D019981:Health Care Sector; D006297:Health Services Accessibility; D006801:Humans; D014481:United States
chemical_list: D059451:Biosimilar Pharmaceuticals