Anna Abram speaking now at #GRxBiosims conference in place of Ned Sharpless (who was replaced on Friday as Acting Commissioner of FDA by Brett Giroir)
Abram touts need for more generics, biosimilars, but also interchangeable biologics (which would be a huge coup for biosimilar industry)
FDA put out new industry advice about interchangeability in May but so far no biosimilar has been approved in U.S. as interchangeable
Interchangeable= when a pharmacist can swap an original biologic for a biosimilar without consulting a doctor
Abram: "Generic drugs are safe&effective," & says FDA has "strengthened our global oversight"
--agreement w European Union allows their regulators to inspect drugs for U.S. market to avoid duplicate inspections
ICYMI: Congress held hearing on generic safety concerns last week
Abram also mentions upcoming March 2020 deadline where some drugs will be regulated as biologics (which she says will mean cheaper insulin)
My story from last Dec on this: news.bloomberglaw.com/pharma-and-lif…
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