ACCISS Study Report | 6 April 2017 – Report | Fact Sheet
The Biosimilar Insulin Regulatory Profile discusses the regulatory pathways and challenges faced by companies seeking marketing authorisation for insulin biosimilars, particularly in highly-regulated markets such as the European Union (EU) and the United States (US). It also includes a case study of two manufacturers who sought marketing authorisation from the European Medicines Agency (EMA) for insulin products.
You can download the full report here.