Biosimilar epoetins and other “follow-on” biologics: Update on the European experiences

Wolfgang Jelkmann (1)

1 Physiology

Summary 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. The present 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.

Mots clés: Medicine

Wolfgang Jelkmann. Biosimilar epoetins and other “follow-on” biologics: Update on the European experiences. American Journal of Hematology, 2010, 85 (10), pp.771. ⟨10.1002/ajh.21805⟩. ⟨hal-00552331⟩