title: 'Biogenerics': the off-patent biotech products.
abstract: The first patents of biopharmaceuticals derived from recombinant DNA will expire shortly, which raises the possibility of marketing generic products ('biogenerics') with limited documentation, similar to that which occurs with conventional pharmaceuticals. We propose the term off-patent biotechnological products (OPBPs) as an alternative to biogenerics when describing such products. It is questionable whether the majority of OPBPs can be classified as similar to the innovator products, considering the size and complexity of the molecules and the many factors that influence biological activity. There are three classes of OPBPs, each of which needs to meet different regulatory demands when seeking marketing authorization.
authors.affiliation: Central Laboratory Animal Institute, Dept of Innovation Studies, Utrecht University, PO Box 80.190, 3508 TD, Utrecht, The Netherlands. h.schellekens@gdl.uu.nl
authors.forename: Huub
authors.initials: H
authors.lastname: Schellekens
authors.forename: Jean-Charles
authors.initials: JC
authors.lastname: Ryff
mesh_terms: D001709:Biotechnology / Q000331:legislation & jurisprudence*; D004274:DNA, Recombinant / Q000627:therapeutic use; D016568:Drugs, Generic; D005060:Europe; D007880:Legislation, Drug; D010330:Patents as Topic; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D004274:DNA, Recombinant; D016568:Drugs, Generic