Subtitle:

Marketing authorization of biosimilar medical products

Publisher:

Komitet Biotechnologii PAN ; Instytut Chemii Bioorganicznej PAN

Description:

Monografia opublikowana w zeszycie Biotechnologia 2(85)'2009

Type of object:

Czasopismo/Artykuł

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:

2009 ; Biotechnologia 5 (2009)-.

Issue:

5

Start page:

57

End page:

74

Detailed Resource Type:

Artykuł

Format:

application/pdf

Resource Identifier:

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

Source:

Biblioteka Instytutu Chemii Bioorganicznej PAN

Language:

pol

Language of abstract:

eng

Temporal coverage:

2009

Rights:

Licencja Creative Commons Uznanie autorstwa-Na tych samych warunkach 4.0

Terms of use:

-

Digitizing institution:

Instytut Chemii Bioorganiczneji Polskiej Akademii Nauk

Original in:

Instytut Chemii Bioorganiczneji Polskiej Akademii Nauk

Projects co-financed by:

Program Operacyjny Polska Cyfrowa, lata 2014-2020, Działanie 2.3 : Cyfrowa dostępność i użyteczność sektora publicznego; środki z Europejskiego Funduszu Rozwoju Regionalnego oraz współfinansowania krajowego z budżetu państwa

Access:

Otwarty