Biological agents and biosimilars

Essential information for the internist

Luca Pasina, Gianluigi Casadei, Alessandro Nobili

Research output: Contribution to journalArticle

10 Citations (Scopus)

Abstract

Biologics embrace a wide range of substances synthesized by cells or living organisms by means of different biological processes, including recombinant DNA technology, controlled gene expression, or antibody technologies. A biosimilar establishes similarity to the reference medicinal product in terms of quality characteristics, biological activity, safety, and efficacy based on a comprehensive comparability exercise. Minimizing development costs and accelerating their market access create a convergence of interests between health services, worried about sustainability, and generic manufacturers. While the demonstration of bioequivalence is sufficient for small synthetic molecules, this approach is not scientifically applicable to a copy of biological drug constituted by large and complex molecules, which are similar but not identical to the originator and are also subject to different post-translational processes. Internists should be confident that the development process of biosimilars ensures a comparable risk-to-benefit balance with the originators. On the basis of available evidence and pharmacovigilance network, there are no grounds to believe that the use of a biosimilar carries more risks for the patient than the use of an originator. Since the first biosimilar was authorized in Europe in 2006, no clinical alerts have raised red flags about the established EMA biosimilar pathway. In this article, we discuss some of the most frequent concerns raised by clinicians about biosimilars and try to explains the scientific principles underlying the biosimilar concept established in the EU in order to license biosimilar drugs.

Original languageEnglish
Pages (from-to)28-35
Number of pages8
JournalEuropean Journal of Internal Medicine
Volume33
DOIs
Publication statusPublished - Sep 1 2016

Fingerprint

Biosimilar Pharmaceuticals
Biological Factors
Technology
Biological Phenomena
Pharmacovigilance
Therapeutic Equivalency
Recombinant DNA
Licensure
Biological Products
Pharmaceutical Preparations
Health Services

Keywords

  • Biological agents
  • Biosimilars
  • Drug information
  • Regulatory

ASJC Scopus subject areas

  • Internal Medicine

Cite this

Biological agents and biosimilars : Essential information for the internist. / Pasina, Luca; Casadei, Gianluigi; Nobili, Alessandro.

In: European Journal of Internal Medicine, Vol. 33, 01.09.2016, p. 28-35.

Research output: Contribution to journalArticle

@article{06fc6de425134f398bce89fbe41959ae,
title = "Biological agents and biosimilars: Essential information for the internist",
abstract = "Biologics embrace a wide range of substances synthesized by cells or living organisms by means of different biological processes, including recombinant DNA technology, controlled gene expression, or antibody technologies. A biosimilar establishes similarity to the reference medicinal product in terms of quality characteristics, biological activity, safety, and efficacy based on a comprehensive comparability exercise. Minimizing development costs and accelerating their market access create a convergence of interests between health services, worried about sustainability, and generic manufacturers. While the demonstration of bioequivalence is sufficient for small synthetic molecules, this approach is not scientifically applicable to a copy of biological drug constituted by large and complex molecules, which are similar but not identical to the originator and are also subject to different post-translational processes. Internists should be confident that the development process of biosimilars ensures a comparable risk-to-benefit balance with the originators. On the basis of available evidence and pharmacovigilance network, there are no grounds to believe that the use of a biosimilar carries more risks for the patient than the use of an originator. Since the first biosimilar was authorized in Europe in 2006, no clinical alerts have raised red flags about the established EMA biosimilar pathway. In this article, we discuss some of the most frequent concerns raised by clinicians about biosimilars and try to explains the scientific principles underlying the biosimilar concept established in the EU in order to license biosimilar drugs.",
keywords = "Biological agents, Biosimilars, Drug information, Regulatory",
author = "Luca Pasina and Gianluigi Casadei and Alessandro Nobili",
year = "2016",
month = "9",
day = "1",
doi = "10.1016/j.ejim.2016.06.005",
language = "English",
volume = "33",
pages = "28--35",
journal = "European Journal of Internal Medicine",
issn = "0953-6205",
publisher = "Elsevier B.V.",

}

TY - JOUR

T1 - Biological agents and biosimilars

T2 - Essential information for the internist

AU - Pasina, Luca

AU - Casadei, Gianluigi

AU - Nobili, Alessandro

PY - 2016/9/1

Y1 - 2016/9/1

N2 - Biologics embrace a wide range of substances synthesized by cells or living organisms by means of different biological processes, including recombinant DNA technology, controlled gene expression, or antibody technologies. A biosimilar establishes similarity to the reference medicinal product in terms of quality characteristics, biological activity, safety, and efficacy based on a comprehensive comparability exercise. Minimizing development costs and accelerating their market access create a convergence of interests between health services, worried about sustainability, and generic manufacturers. While the demonstration of bioequivalence is sufficient for small synthetic molecules, this approach is not scientifically applicable to a copy of biological drug constituted by large and complex molecules, which are similar but not identical to the originator and are also subject to different post-translational processes. Internists should be confident that the development process of biosimilars ensures a comparable risk-to-benefit balance with the originators. On the basis of available evidence and pharmacovigilance network, there are no grounds to believe that the use of a biosimilar carries more risks for the patient than the use of an originator. Since the first biosimilar was authorized in Europe in 2006, no clinical alerts have raised red flags about the established EMA biosimilar pathway. In this article, we discuss some of the most frequent concerns raised by clinicians about biosimilars and try to explains the scientific principles underlying the biosimilar concept established in the EU in order to license biosimilar drugs.

AB - Biologics embrace a wide range of substances synthesized by cells or living organisms by means of different biological processes, including recombinant DNA technology, controlled gene expression, or antibody technologies. A biosimilar establishes similarity to the reference medicinal product in terms of quality characteristics, biological activity, safety, and efficacy based on a comprehensive comparability exercise. Minimizing development costs and accelerating their market access create a convergence of interests between health services, worried about sustainability, and generic manufacturers. While the demonstration of bioequivalence is sufficient for small synthetic molecules, this approach is not scientifically applicable to a copy of biological drug constituted by large and complex molecules, which are similar but not identical to the originator and are also subject to different post-translational processes. Internists should be confident that the development process of biosimilars ensures a comparable risk-to-benefit balance with the originators. On the basis of available evidence and pharmacovigilance network, there are no grounds to believe that the use of a biosimilar carries more risks for the patient than the use of an originator. Since the first biosimilar was authorized in Europe in 2006, no clinical alerts have raised red flags about the established EMA biosimilar pathway. In this article, we discuss some of the most frequent concerns raised by clinicians about biosimilars and try to explains the scientific principles underlying the biosimilar concept established in the EU in order to license biosimilar drugs.

KW - Biological agents

KW - Biosimilars

KW - Drug information

KW - Regulatory

UR - http://www.scopus.com/inward/record.url?scp=84991216011&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84991216011&partnerID=8YFLogxK

U2 - 10.1016/j.ejim.2016.06.005

DO - 10.1016/j.ejim.2016.06.005

M3 - Article

VL - 33

SP - 28

EP - 35

JO - European Journal of Internal Medicine

JF - European Journal of Internal Medicine

SN - 0953-6205

ER -