SCOTUS allows early notice from biosimilar applicants
12-06-2017
Biosimilars Council urges SCOTUS to limit biologics exclusivity period
22-02-2017
iko636 / iStockphoto.com
The US Court of Appeals for the Federal Circuit erred in holding that biosimilar applicants must give 180 days’ pre-marketing notice after an application has been approved by the US Food and Drug Administration (FDA), according to the acting solicitor general.
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