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…
The harmonisation of different regulatory environments in the EU member states will help generic drugs enter the market, resulting in reduced prices for medicine and better patient access, Jacek Glinka told EURACTIV.com in an interview.
Jacek Glinka is the president of the Medicines for Europe, which represents the European generic, biosimilar and valued added pharmaceutical industries.
He spoke with EURACTIV.com’s Sarantis Michalopoulos and Hannah Black.