Subtitle:

Marketing authorization of biosimilar medical products

Publisher:

Committee on Biotechnology PAS ; Institute of Bioorganic Chemistry PAS

Description:

Monografia opublikowana w zeszycie Biotechnologia 2(85)'2009

Type of object:

Journal/Article

Abstract:

Biosimilars present a new category of products when compared with conventional generics. While the demonstration of a pharmacokinetic similarity is the main method to demonstrate therapeutic equivalence of generic medicinal products, a number of issues will make the approval of biosimilars more complicated. Therefore, the centralised procedure of marketing authorization is the only procedure allowed for these products in EU. New manufacturers will need to ensure that their biopharmaceutical has similar efficacy and safety profile to the reference product through more extensive clinical trials than the limited testing done for generic versions of low-mo- lecular-weight chemical medicines. The primary issue of concern for the safety of these agents is the potential for immunogenicity. This review presents background information on the differences between biosimilars and low-molecular-weight generic drugs and the current regulatory situation, and provides information on the main sources of variability of biosimilars.

Relation:

Biotechnologia 5 (2009)-.

Issue:

5

Start page:

57

End page:

74

Detailed Resource Type:

Article

Format:

application/pdf

Resource Identifier:

0860-7796 ; oai:rcin.org.pl:72688 ; IChB B-80

Source:

Library of Institute of Bioorganic Chemistry PAS

Language:

pol

Language of abstract:

eng

Temporal coverage:

2009

Rights:

Creative Commons Attribution BY-SA 4.0 license

Terms of use:

Copyright-protected material. [CC BY-SA 4.0] May be used within the scope specified in Creative Commons Attribution BY-SA 4.0 license, full text available at:

Digitizing institution:

Institute of Bioorganic Chemistry of the Polish Academy of Science

Original in:

Institute of Bioorganic Chemistry of the Polish Academy of Science

Projects co-financed by:

Operational Program Digital Poland, 2014-2020, Measure 2.3: Digital accessibility and usefulness of public sector information; funds from the European Regional Development Fund and national co-financing from the state budget.

Access:

Open