The ruling, which Judge Gregory B. Williams issued under seal June 20 in the US District Court for the District of Delaware, is a rarity among biosimilars cases, which often settle before preliminary injunction requests are resolved.
Unlike lawsuits to block generic versions of traditional drugs under the Hatch-Waxman Act, suing under the Biologics Price Competition and Innovation Act doesn’t trigger an automatic 30-month stay of US Food and Drug Administration approval for ...
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