General characteristics of clinical trials for biosimilar drugs

Year 2021, Volume: 34 Issue: 2, 89 - 94, 31.05.2021

Ahmet Akıcı Caner Vızdıklar

https://doi.org/10.5472/marumj.942752

Abstract

Biosimilar is a highly similar product to biological reference medicinal product. The development, licensing and clinical use of these
products differ from the implementations of conventional drugs shaped on the concept of equivalence in various aspects. Negative
attitudes about generic drugs, many of which are thought to be based on lack of knowledge, are still substantial. There is concern that
the problem may reach more serious dimensions in the use of biosimilars, which are known to be more complex compared to these.
Knowing the prominent critical aspects of the development process of the biosimilars may contribute to the solution of this problem
that causes significant difficulties in practice.
In all conventional and biological products, the innovative drug researches consist of the preclinical phase followed by the successive
phases I-IV. The first three phases are carried out before the license. The clinical trials required for licensing of generics are limited
by bioequivalence studies. However, in biosimilars, this process is more complex due to the nature of biological products. Adequate
quality, clinical efficacy and safety data are needed on the comparability basis of the reference products and their biosimilar. Phase
I and III are generally required for biosimilarity, although it may vary per product. Although, these phases are perceived as classical
phase studies, they differ considerably from those in the development process of reference drug in terms of design, purpose, content
and flexibility. Approaches that do not pay attention to these details sufficiently, can cause many problems such as the advantages
of biosimilars remain limited, risk management cannot be performed effectively, loss of trust, delay in product supplying, unfair
competition, etc. The general characteristics of clinical trials and the details of the subject specifically for biosimilars are mentioned
in this review article.

Keywords

Biosimilarity, Biological drug, Generic, Clinical trials

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