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International Pharmaceutical Regulatory Monitor
> India Promises Fewer Clinical Hurdles for Biosimilars Under Some Conditions
International Pharmaceutical Regulatory Monitor
July 2012
| Vol.
40 No.
7
India Promises Fewer Clinical Hurdles for Biosimilars Under Some Conditions
As with its U.S. Food and Drug Administration (FDA) counterparts, Indian regulators promise fewer clinical trials for biosimilars makers who can prove their product closely matches its reference product, new guidelines state.
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