Medication Approvals

On Wednesday, Jan. 7, 2015, a U.S. Food and Drug Administration (FDA) Advisory Panel recommended approval of the first U.S. biosimilar medication Zarxio, which is Sandoz’s (a unit of Novartis) equivalent to Neupogen currently manufactured by Amgen. According to the advisory panel, Zarxio should be approved for the same five conditions Neupogen is approved to treat. The FDA will most likely make a decision on the biosimilar medication Zarxio in March, and will consider the advisory panel’s recommendation at that time.

One of MPA’s legislative priorities this year is ensuring that when pharmacists dispense a FDA-approved interchangeable biosimilar medication, there isn’t undue burden placed on them to notify the prescriber of the change. MPA advocates that biosimilar medications should be treated as other generic medications are currently, with no notification to the prescriber that a switch to or from a brand name to interchangeable generic medication has occurred. MPA will continue to monitor any legislation and keep you up-to-date on the biosimilar guidance documents the FDA will release this year.


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