Rise Of The Biosimilar Formulary: CVS Excludes Lantus, Neupogen For 2017
Zarxio and Basaglar will be the beneficiaries of the cost-cutting move, although how much it will help the follow-on products remains unclear.
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Sandoz announces 'complete response' letter for its pegfilgrastim 351(k) filing, suggesting it’s a tough molecule to crack at the agency.
The US Court of Appeals for the Federal Circuit has ruled that a biosimilar applicant is required to provide 180-day notice of its commercial marketing after Food and Drug Administration approval whether or not it engages in the patent information exchange process laid out in the biosimilar statute1. But the court suggested that notification could be given at the time of tentative approval, which would prevent a marketing delay for biosimilar versions of newer biologics.
Eli Lilly/Boehringer Ingelheim’s insulin glargine product had already received tentative approval from FDA. The final approval clears the way for an eventual copycat version of Sanofi’s Lantus.