Cargando…

Epoetin Biosimilars in the Treatment of Renal Anemia: What Have We Learned from a Decade of European Experience?

Biosimilars are biological medicines that are approved via stringently defined regulatory pathways on the basis that comparable safety, efficacy, and quality have been demonstrated to their reference medicine. The advantage of biosimilar drugs is that they may be less expensive than the reference me...

Descripción completa

Detalles Bibliográficos
Autores principales: Goldsmith, David, Dellanna, Frank, Schiestl, Martin, Krendyukov, Andriy, Combe, Christian
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5951862/
https://www.ncbi.nlm.nih.gov/pubmed/29500617
http://dx.doi.org/10.1007/s40261-018-0637-1
_version_ 1783323084541919232
author Goldsmith, David
Dellanna, Frank
Schiestl, Martin
Krendyukov, Andriy
Combe, Christian
author_facet Goldsmith, David
Dellanna, Frank
Schiestl, Martin
Krendyukov, Andriy
Combe, Christian
author_sort Goldsmith, David
collection PubMed
description Biosimilars are biological medicines that are approved via stringently defined regulatory pathways on the basis that comparable safety, efficacy, and quality have been demonstrated to their reference medicine. The advantage of biosimilar drugs is that they may be less expensive than the reference medicine, allowing for greater patient access and cost savings in already stretched healthcare budgets. Biosimilar epoetins have been available in Europe for a decade. Complementing in vitro and preclinical characterization, and pharmacokinetic/pharmacodynamic studies, clinical trials provided the additional data needed to reassure European authorities that biosimilar epoetins were sufficiently similar to the reference epoetin to warrant approval. Post-approval, real-world studies have provided further evidence that biosimilar epoetins are an effective and well-tolerated option for the treatment of renal anemia, with ongoing pharmacovigilance and observational studies monitoring for any unexpected long-term signals that have not been identified in clinical development studies. As the evidence and experience with these products increase, many of the initial concerns are being alleviated. Nephrologists can be increasingly confident that European Medicines Agency-approved biosimilars offer high-quality, affordable, effective alternatives to existing reference medicines used to treat renal anemia, and may help yield cost savings and improve patient access.
format Online
Article
Text
id pubmed-5951862
institution National Center for Biotechnology Information
language English
publishDate 2018
publisher Springer International Publishing
record_format MEDLINE/PubMed
spelling pubmed-59518622018-05-18 Epoetin Biosimilars in the Treatment of Renal Anemia: What Have We Learned from a Decade of European Experience? Goldsmith, David Dellanna, Frank Schiestl, Martin Krendyukov, Andriy Combe, Christian Clin Drug Investig Current Opinion Biosimilars are biological medicines that are approved via stringently defined regulatory pathways on the basis that comparable safety, efficacy, and quality have been demonstrated to their reference medicine. The advantage of biosimilar drugs is that they may be less expensive than the reference medicine, allowing for greater patient access and cost savings in already stretched healthcare budgets. Biosimilar epoetins have been available in Europe for a decade. Complementing in vitro and preclinical characterization, and pharmacokinetic/pharmacodynamic studies, clinical trials provided the additional data needed to reassure European authorities that biosimilar epoetins were sufficiently similar to the reference epoetin to warrant approval. Post-approval, real-world studies have provided further evidence that biosimilar epoetins are an effective and well-tolerated option for the treatment of renal anemia, with ongoing pharmacovigilance and observational studies monitoring for any unexpected long-term signals that have not been identified in clinical development studies. As the evidence and experience with these products increase, many of the initial concerns are being alleviated. Nephrologists can be increasingly confident that European Medicines Agency-approved biosimilars offer high-quality, affordable, effective alternatives to existing reference medicines used to treat renal anemia, and may help yield cost savings and improve patient access. Springer International Publishing 2018-03-02 2018 /pmc/articles/PMC5951862/ /pubmed/29500617 http://dx.doi.org/10.1007/s40261-018-0637-1 Text en © The Author(s) 2018 Open AccessThis article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License (http://creativecommons.org/licenses/by-nc/4.0/), which permits any noncommercial use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.
spellingShingle Current Opinion
Goldsmith, David
Dellanna, Frank
Schiestl, Martin
Krendyukov, Andriy
Combe, Christian
Epoetin Biosimilars in the Treatment of Renal Anemia: What Have We Learned from a Decade of European Experience?
title Epoetin Biosimilars in the Treatment of Renal Anemia: What Have We Learned from a Decade of European Experience?
title_full Epoetin Biosimilars in the Treatment of Renal Anemia: What Have We Learned from a Decade of European Experience?
title_fullStr Epoetin Biosimilars in the Treatment of Renal Anemia: What Have We Learned from a Decade of European Experience?
title_full_unstemmed Epoetin Biosimilars in the Treatment of Renal Anemia: What Have We Learned from a Decade of European Experience?
title_short Epoetin Biosimilars in the Treatment of Renal Anemia: What Have We Learned from a Decade of European Experience?
title_sort epoetin biosimilars in the treatment of renal anemia: what have we learned from a decade of european experience?
topic Current Opinion
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5951862/
https://www.ncbi.nlm.nih.gov/pubmed/29500617
http://dx.doi.org/10.1007/s40261-018-0637-1
work_keys_str_mv AT goldsmithdavid epoetinbiosimilarsinthetreatmentofrenalanemiawhathavewelearnedfromadecadeofeuropeanexperience
AT dellannafrank epoetinbiosimilarsinthetreatmentofrenalanemiawhathavewelearnedfromadecadeofeuropeanexperience
AT schiestlmartin epoetinbiosimilarsinthetreatmentofrenalanemiawhathavewelearnedfromadecadeofeuropeanexperience
AT krendyukovandriy epoetinbiosimilarsinthetreatmentofrenalanemiawhathavewelearnedfromadecadeofeuropeanexperience
AT combechristian epoetinbiosimilarsinthetreatmentofrenalanemiawhathavewelearnedfromadecadeofeuropeanexperience