Rhythm
Journal Title: Generics and Biosimilars Initiative Journal - Year 2012, Vol 1, Issue 1
Abstract
Clinical biosimilar data should be accessible to all Calls are growing for biosimilar manufacturers to publish their data in the public domain, particularly when developing versions of monoclonal antibodies that are associated with potential survival benefits. One of GaBI Online’s readers totally agrees with this message. However, few others wonder why biosimilar producers must handle safety and efficacy data with transparency while the originator will have its data protected through temporary periods of exclusivity. Leaving aside economic reasons, are there any public health or access to information arguments that justify meaningful differences of treatment between both sets of data?
Authors and Affiliations
GaBI Journal Editor
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- EP ID EP355205
- DOI 10.5639/gabij.2012.0101.012
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