GENERICS AND BIOSIMILARS INITIATIVE JOURNAL
Official Journal of the Generics and Biosimilars Initiative
Volume 9 / Year 2020 / Issue 2
Special Report
Biosimilars markets: US and EU compared
Author(s): GaBI Journal Editor
Page: 90-2Abstract: Differences between the US and European regulatory processes can lead to differences in the time taken for biosimilar approval. The European Medicines Agency is in some cases quicker to approve biosimilar drugs and Europe has overall more approved biosimilars, whilst the US approved the first biosimilar in 2015. Whatever the market, there are a […]
Clinical trials for trastuzumab biosimilars
Author(s): GaBI Journal Editor
Page: 84-9Abstract: Clinical trials must demonstrate biosimilarity for regulatory marketing approval to be granted. The GaBI Journal has conducted a search for clinical trials that have been, or are being, carried out for trastuzumab biosimilars. Submitted: 26 March 2020; Revised: 2 April 2020; Accepted: 2 April 2020; Published online first: 15 April 2020 Roche’s originator trastuzumab […]
