BioVoice News March 2017 Issue 10 Volume 1 | Page 33

name as for the reference product . In 2015 , the US FDA issued draft guidance on the subject of non-proprietary naming of biosimilars . This guidance recommends that all biologicals should have non-proprietary names that include a fourletter suffix to distinguish them from each other . The suffix would be composed of four lowercase letters and not carry any meaning . The proposed approach is intended with a view to clearly identifying biological products to improve pharmacovigilance , and , preventing any unintended substitution . However , a number of industry stakeholders , including the USP have requested for alternative approaches to be considered .
While the interchangability guidance from the US FDA is awaited , Sandoz recently reported study findings that show lack of safety and efficacy impact from multiple back and forth switches between the it ’ s etanercept biosimilar and the originator product .
Also , we expect to see more products obtaining marketing approval on the basis of lean clinical data packages ( especially where validated PD markers are available ), supported by strong quality comparability , in vitro biological activity evidence and clinical PK- PD studies .
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