ACCISS Study Report | Biosimilar Insulin Regulatory Profile

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.

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