title: Similar biological medicinal products currently licensed in the European union--overview of non-clinical study programs.
abstract: In the EU, a regulatory framework has been established which defines general conditions for marketing authorisation approval of similar biological medicinal products (SBMPs). In addition, the framework provides product-class specific recommendations for non-clinical evaluation of specific SBMPs containing as active substance recombinant somatropin, granulocyte-colony stimulating factor (G-CSF), erythropoietin, interferon alpha, insulin or low molecular weight heparins. During the last years, a number of SBMPs have been succesfully licensed in the EU. This article summarizes the non-clinical evaluations performed for these medicinal products and provides a comparison with the current requests for non-clinical evaluation as laid down in the respective EU regulatory guidelines.
authors.affiliation: Federal Institute for Drugs and Medical Devices, Kurt-Georg-Kiesinger-Allee 3, Bonn, Germany. Hans-Karl.Heim@bfarm.de.
authors.forename: Hans-Karl
authors.initials: HK
authors.lastname: Heim
mesh_terms: D000818:Animals; D016207:Cytokines / Q000009:adverse effects / Q000627:therapeutic use*; D004353:Drug Evaluation, Preclinical / Q000379:methods* / Q000592:standards; D005062:European Union; D017408:Guidelines as Topic; D006801:Humans; D007880:Legislation, Drug; D008004:Licensure; D011994:Recombinant Proteins / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D016207:Cytokines; D011994:Recombinant Proteins