Teva Launches First-Ever CREATES Act Suit
Seeks Help With Fabry Disease Generic Development
Amicus should to be forced to sell samples of Galafold (migalastat) for bioequivalence and other testing, Teva argues in what appears to be the initial case brought under the 2019 law intended to smooth the development of ANDAs.
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US FDA has 120 days to review generic sponsors’ requests for letters to help them obtain product samples, but will not send them to the reference product company.
Biosimilar sponsors need multiple reference product lots and expiration dates, and questions remain about whether they can obtain enough to fulfill all regulatory requirements under a CREATES Act mandate, Teva attorney says.
Teva has dismissed its suit against Amicus Therapeutics after the latter agreed to provide requested quantities of its Fabry disease treatment Galafold. The quick resolution of the complaint illustrates the success of the CREATES Act in halting the drug supply dispute but leaves some unanswered questions.