Biosimilar medicines are a part of today’s therapeutic armamentarium – a “must-have weaponry” and a “catalyst for equal access” for physicians [1]. They have a track record of delivered healthcare benefits over the years.
Armed with over 10 years of positive clinical experience, physicians and patients are now focusing conversations on the long-term future of biosimilars, exploring how best to introduce biosimilar medicines in medical practice and ensure feedback in the post-authorisation phase.
So, what are the important questions remaining to be addressed?
US FDA interchangeability guidance adds another level of confusion over the concept of biosimilar switching, says Medicines for Europe.
In the EU, where biosimilars have been present for over a decade, the definitions of switching, interchangeability and substitution are as follows…