Biosimilar epoetins and other "follow-on" biologics: update on the European experiences.
After the patents of biopharmaceuticals have expired, based on specific regulatory approval pathways copied products ("biosimilars" or "follow-on biologics") have been launched in the EU. This article summarizes experiences with hematopoietic medicines, namely the epoetins (two biosimilars traded under five different brand names) and the filgrastims (two biosimilars, six brand names). Physicians and pharmacists should be familiar with the legal and pharmacological specialities of biosimilars: The production process can differ from that of the original, clinical indications can be extrapolated, glycoproteins contain varying isoforms, the formulation may differ from the original, and biopharmaceuticals are potentially immunogenic. Only on proof of quality, efficacy and safety, biosimilars are a viable option because of their lower costs.
Jelkmann
Wolfgang
W
Institute of Physiology, University of Luebeck, Ratzeburger Allee 160, Luebeck, Germany. jelkmann@physio.uni-luebeck.de
D000740:Anemia / Q000209:etiology / Q000628:therapy; D000970:Antineoplastic Agents / Q000009:adverse effects; D001688:Biological Products / Q000191:economics / Q000493:pharmacokinetics / Q000592:standards / Q000627:therapeutic use*; D002908:Chronic Disease; D004363:Drug Utilization; D004921:Erythropoietin / Q000191:economics / Q000276:immunology / Q000493:pharmacokinetics / Q000627:therapeutic use*; D005062:European Union; D000069585:Filgrastim; D016179:Granulocyte Colony-Stimulating Factor / Q000627:therapeutic use; D017408:Guidelines as Topic; D006801:Humans; D007518:Isoantibodies / Q000096:biosynthesis; D007674:Kidney Diseases / Q000097:blood / Q000150:complications; D007880:Legislation, Drug; D040541:Marketing; D009369:Neoplasms / Q000097:blood / Q000150:complications / Q000188:drug therapy; D010330:Patents as Topic; D011092:Polyethylene Glycols; D011786:Quality Control; D011994:Recombinant Proteins / Q000191:economics / Q000276:immunology / Q000493:pharmacokinetics / Q000627:therapeutic use; D012010:Red-Cell Aplasia, Pure / Q000209:etiology; D013810:Therapeutic Equivalency; D014944:World Health Organization
D000970:Antineoplastic Agents; D001688:Biological Products; D007518:Isoantibodies; D011994:Recombinant Proteins; D004921:Erythropoietin; D016179:Granulocyte Colony-Stimulating Factor; C455861:pegfilgrastim; D011092:Polyethylene Glycols; D000069585:Filgrastim