Document Detail

Clinical safety of biosimilar recombinant human erythropoietins.
MedLine Citation:
PMID:  22880621     Owner:  NLM     Status:  MEDLINE    
INTRODUCTION: A "biosimilar" or "similar biological medicinal product" is a biological agent that is similar in terms of quality, safety, and efficacy to an authorized reference biological medicine. Since the expiration of the epoetin alfa patent in Europe, three agents have received marketing authorization from the European Medicines Agency: Binocrit (epoetin alfa; aka Abseamed and Epoetin Alfa Hexal), Retacrit (epoetin zeta; aka Silapo), and Eporatio (epoetin theta; aka Biopoin and Ratioepo).
AREAS COVERED: Using the EMA dossiers and journal publications, this article reviews clinical safety data for these products, with emphasis on serious/severe adverse events and a special consideration of immunogenicity, venous thromboembolism, and mortality.
EXPERT OPINION: A review of the available safety evidence shows that all three agents discussed have similar safety profiles. None were statistically higher on safety parameters to what is known about ESA as a class, when stratified by population. As with ESAs in general, immunogenicity, venous thromboembolism, and mortality are all concerns. What is known about ESAs regarding safety can be extended to biosimilar erythropoietins. Since biosimilars are unique, complex biological molecules, safety profiles may evolve from common to differentiated, once long-term product-specific safety data are available. Large-sample, long-term, observational studies of real-world practice will provide the heterogeneity and statistical power to demonstrate product-specific effectiveness and safety profiles. Statistically, out of the commercially available formulations of the three products reviewed, no single product is less or more safe.
Ivo Abraham; Karen MacDonald
Publication Detail:
Type:  Comparative Study; Journal Article; Research Support, U.S. Gov't, P.H.S.; Review     Date:  2012-08-13
Journal Detail:
Title:  Expert opinion on drug safety     Volume:  11     ISSN:  1744-764X     ISO Abbreviation:  Expert Opin Drug Saf     Publication Date:  2012 Sep 
Date Detail:
Created Date:  2012-08-23     Completed Date:  2013-01-21     Revised Date:  2013-11-06    
Medline Journal Info:
Nlm Unique ID:  101163027     Medline TA:  Expert Opin Drug Saf     Country:  England    
Other Details:
Languages:  eng     Pagination:  819-40     Citation Subset:  IM    
Center for Health Outcomes and Pharmaco-Economic Research, College of Pharmacy, University of Arizona, 1295 N. Martin Ave., Matrix 45, Tucson, AZ 85721, USA.
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MeSH Terms
Biosimilar Pharmaceuticals / adverse effects*,  chemistry
Drug Hypersensitivity / epidemiology
Drug Monitoring
Erythropoietin / adverse effects*,  chemistry
Hematinics / adverse effects*,  chemistry
Recombinant Proteins / adverse effects,  chemistry
Venous Thromboembolism / chemically induced,  epidemiology,  mortality
Reg. No./Substance:
0/Biosimilar Pharmaceuticals; 0/EPO protein, human; 0/Hematinics; 0/Recombinant Proteins; 0/epoetin theta; 0/epoetin zeta; 11096-26-7/Erythropoietin; 113427-24-0/epoetin alfa

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