Highlights
- •Biologics are a wide range of substances synthesized by cells or living organisms.
- •A biosimilar is a copy of an authorized original biological medicinal product.
- •Safety and efficacy of biosimilars are comparable to the originator's.
- •The post-marketing safety evaluation is stringent as for any new biological product.
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
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Article info
Publication history
Published online: June 21, 2016
Accepted:
June 1,
2016
Received in revised form:
May 31,
2016
Received:
May 19,
2016
Identification
Copyright
© 2016 European Federation of Internal Medicine. Published by Elsevier B.V. All rights reserved.
