‘Similar biologics’ approved and marketed in India
Journal Title: Generics and Biosimilars Initiative Journal - Year 2013, Vol 2, Issue 1
Abstract
There have been established guidelines for approving generic versions of small molecule chemical drugs in India for some time already. However, no specific guidelines for ‘similar biologics’, as the Indian regulatory authorities call these products, have existed in India until recently. This has been the case despite the fact that the requirements for granting regulatory approval for such ‘similar biologics’ required more data than for a simple generic drug application [1].
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GaBI Journal Editor
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- EP ID EP355125
- DOI 10.5639/gabij.2013.0201.006
- Views 97
- Downloads 0
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