2015 | NMIC Bulletin Vol. 21 No. 5 Dec 2015

1 December, 2015

Update on biosimilar medicines

A biosimilar medicine is a biological medicine that is developed to be highly similar to an approved (reference) biological medicine
A biosimilar medicine must establish similarity to the key characteristics of the molecular and biological activity of the reference medicine
Biosimilar medicines are not the same as generic (chemical-based) medicines; therefore they may not be regarded as interchangeable with the reference biological medicine
Biological and biosimilar medicines should be prescribed by brand name to enable ongoing safety monitoring of individual medicines