Biosimilar medicine development is target-orientated, comparative, and follows a stepwise approach9,13,14. Highly sophisticated analytical tools allow for a detailed characterisation of the biosimilar medicine and the reference product13,14. Due to technological advances, biosimilar medicines are usually better characterised than their reference products, which were characterised at the time of their initial approval 10 or 20 years earlier5,15.
The pillars of a biosimilar product development and marketing approval: