biosimilar medicine

Formal Definition

A biological medicinal product that contains a version of the active substance of an already authorised original biological medicinal product (reference medicinal) product in the European Economic Area, and which has shown similarity to the reference product in terms of quality characteristics, biological activity, safety and efficacy based on a comprehensive comparability exercise.

HMA Guideline on good pharmacovigilance practices 2019

A biosimilar medicine is a biological medicine which is similar to another biological medicine that has already been authorised for use. Biosimilar medicines are commonly known as biological generic medicines

  • Categories: Medicines