[Clinical pharmacologic principles of the development and application of follow-on biological medicinal products].
The structure of the biological drug proteins cannot be unequivocally determined due to their large molecular weight and complex structure. As a consequence, the production of a follow-on biological product completely identical with the originator molecule is not possible yet. In order to emphasize this difference the European Medicines Agency (EMEA) restricted the term of generic medicines exclusively to follow-on drugs containing small molecular weight, precisely identifiable chemicals as the active agent. In the case of follow-on medicines containing large molecular weight proteins as the active ingredient, the term similar biological medicinal product was introduced. The similarity of the pharmacokinetic properties, the effectiveness, safety and the quality of the follow-on drug must be proven in comparative studies with the reference biological product. For the evaluation of the possible differences in the immunogenicity of the originator and follow-on products, long-term observations have to be carried out with the biosimilar drugs even after marketing authorization has been obtained. The evaluation of adverse reactions should be done separately for each biosimilar product.
Kerpel-Fronius
Sándor
S
Semmelweis Egyetem, Altalános Orvostudományi Kar Farmakológiai és Farmakoterápiás Intézet Budapest Pf. 370 1445. kerfro@pharma.sote.hu
D001688:Biological Products / Q000494:pharmacology* / Q000627:therapeutic use*; D015195:Drug Design; D006801:Humans
D001688:Biological Products