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

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