On FDA's advice, Inflectra sponsor conducted three-way pharmacokinetic bridging study to justify relevance of clinical comparative efficacy data using European version of Remicade.
Like Zarxio sponsor Sandoz Inc. before it, Celltrion Inc. is leveraging an extensive foreign clinical development program to make the case for biosimilarity to a US reference product.
The clinical development program for Inflectra (CT-P13) included nine completed studies, only one of which was conducted specifically to support...
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Novartis failed to stop MSN from launching a generic Entresto and saw an earlier temporary ban lifted, potentially opening the market to competition before a final decision on a US patent dispute.
The FDA is testing a new artificial intelligence tool to help generic drug developers automate maximum daily dose calculations.
After the abrupt departure of CBER’s director, it seems FDA, and Vinay Prasad in particular, would likely have been well served by hearing from an advisory committee before requesting the suspension in sales of Sarepta’s DMD gene therapy Elevidys.
