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 In 2015, the US FDA issued draft guidance on the subject of non-proprietary naming of biosimilars.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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