open access

Vol 7, No 3 (2011)
Review paper
Published online: 2011-08-23
Get Citation

Biotechnological original drugs and biosimilars — some problems with their registration and administration on example of granulocyte colony stimulating factors (G-CSF)

Włodzimierz Bialik
Onkol. Prak. Klin 2011;7(3):132-137.

open access

Vol 7, No 3 (2011)
REVIEW ARTICLES
Published online: 2011-08-23

Abstract

Recently, there have been appearing follow on forms to original biotechnological drugs (so-called biosimilars). Those drugs are not generics which significantly influences the way they are registered — only centralized procedure is applicable. Generally, the procedure does not require to carry on comparative clinical trials in all indications (extrapolation is possible) which may be doubtful in some cases. Majority of UE countries accepted special law regulations to prevent automatic substitution of original drugs by biosimilars. Some other important issues such as pharmacovigilance and naming were also briefly discussed.
Onkol. Prak. Klin. 2011; 7, 3: 132–137

Abstract

Recently, there have been appearing follow on forms to original biotechnological drugs (so-called biosimilars). Those drugs are not generics which significantly influences the way they are registered — only centralized procedure is applicable. Generally, the procedure does not require to carry on comparative clinical trials in all indications (extrapolation is possible) which may be doubtful in some cases. Majority of UE countries accepted special law regulations to prevent automatic substitution of original drugs by biosimilars. Some other important issues such as pharmacovigilance and naming were also briefly discussed.
Onkol. Prak. Klin. 2011; 7, 3: 132–137
Get Citation

Keywords

biosimilars; generics; safety; comparative trials

About this article
Title

Biotechnological original drugs and biosimilars — some problems with their registration and administration on example of granulocyte colony stimulating factors (G-CSF)

Journal

Oncology in Clinical Practice

Issue

Vol 7, No 3 (2011)

Article type

Review paper

Pages

132-137

Published online

2011-08-23

Bibliographic record

Onkol. Prak. Klin 2011;7(3):132-137.

Keywords

biosimilars
generics
safety
comparative trials

Authors

Włodzimierz Bialik

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