Arnold G. Vulto is a professor, Dept. of Hospital Pharmacy, Erasmus University Medical Center, Rotterdam, The Netherlands and Dept. of Pharmaceutical and Pharmacological Sciences, Catholic University Leuven, Belgium.
Challenges with Successful Commercialization of Biosimilars
May 15th 2019This article presents some key differences between the US and European regulation of biosimilars, including naming conventions and pharmacovigilance of biosimilars, and the impact of biosimilars on commercialization and affordability of biotherapeutics.