GENERICS AND BIOSIMILARS INITIATIVE JOURNAL
Official Journal of the Generics and Biosimilars Initiative
Volume 3 / Year 2014 / Issue 1
Commentary
Biosimilar monoclonal antibodies approved for use in the EU
Author(s): Meenu Wadhwa, PhD, Robin Thorpe, PhD, FRCPath
Page: 9-10Abstract: Two biosimilar TNF-alfa monoclonal antibody (mAb) products were approved for clinical use in the European Union on 10 September 2013, following a positive opinion by the Committee for Medicinal Products for Human Use (CHMP) in July 2013. The products, with trade names Remsima and Inflectra (INNs infliximab) contain an identical mAb. This approval shows […]
The biosimilar name debate: what’s at stake for public health
Author(s): Emily A Alexander, JD
Page: 10-2Abstract: As the number of innovator biologics and biosimilars increases worldwide, a growing debate has focused on how these products should be named. The simple concept of a name can have significant impact on prescribing, dispensing, and adverse event reporting processes and, consequently, patient safety. Submitted: 2 January 2014; Revised: 10 January 2014; Accepted: 11 […]
