Biosimilar Interchangeability: EU and FDA Approaches to Device Switching
European Pharmaceutical Manufacturer
For over 18 years European Pharmaceutical Manufacturer has informed readers of the latest news, opinions, developments and breakthroughs on topics ranging from the pharma/biopharma manufacturing supply chain to formulation and distribution.
In Europe, a fifth of the total spend on biologics is already exposed to competition from biosimilars. Meanwhile, in the US, just under a fifth of the biologics market is exposed to biosimilar competition, and three-fifths of the market has the potential for biosimilar development.
In this article, Darren Mansell, our Regulatory Affairs Manager, discusses the regulatory implications of making device changes for combination products. Get the full story on page 21 in the link below.