Biosimilar

A biological medicine that is developed to be similar to an existing biological medicine (the 'reference medicine'). Biosimilar medicines can only be marketed following the patent expiry of the reference medicine.
Biosimilars are not the same as generics, which have simpler chemical structures and are considered to be identical to their reference medicines.
The active substance of a biosimilar and its reference medicine is essentially the same biological substance, though there may be minor differences due to their complex nature and production methods. Like the reference medicine, the biosimilar has a degree of natural variability. 
Synonym: similar biological medicinal product, biosimilar medicinal product, biosimilar medicine

In German: Biosimilar
Biologisches Arzneimittel, das einem bereits zugelassenen biologischen Arzneimittel (Referenzarzneimittel) sehr ähnlich ist. Biosimilars sind nicht dasselbe wie Generika, die einfachere chemische Strukturen aufweisen und mit dem Referenzarzneimittel ident sind. Biosimilars sind nach den gleichen Standards für pharmazeutische Qualität, Sicherheit und Wirksamkeit zugelassen, die für alle biologischen Arzneimittel gelten. Die Europäische Arzneimittelagentur (EMA) ist für die Bewertung der meisten Anträge auf Vermarktung von Biosimilars in der Europäischen Union (EU) zuständig.

Last update: 05 September 2021

 

Previous versions:

A biological medicine that is developed to be similar to an existing biological medicine (the 'reference medicine'). Biosimilar medicines can only be marketed following the patent expiry of the reference medicine.
Biosimilars are not the same as generics, which have simpler chemical structures and are considered to be identical to their reference medicines.
The active substance of a biosimilar and its reference medicine is essentially the same biological substance, though there may be minor differences due to their complex nature and production methods. Like the reference medicine, the biosimilar has a degree of natural variability. When approved, its variability and any differences between it and its reference medicine will have been shown not to affect safety or effectiveness.
An authorised biosimilar is generally used at the same dose to treat the same conditions. If there are specific precautions to be considered when taking the reference medicine, the same will generally apply to the biosimilar.
Biosimilars can only be authorized for use once the period of data exclusivity on the original “reference” biological medicine has expired. In general, this means that the biological reference medicine must have been authorized for at least 10 years before a similar biological medicine can be made available by another company.