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Latest From Sue Sutter
In unveiling the agency’s Biosimilar Action Plan, FDA's Gottlieb continued his pattern of provocative remarks by criticizing brand company practices and payment models that impede biosimilar competition and could ultimately undermine innovation. He also called for more action by the Federal Trade Commission and downplayed the impact interchangeability could have on biosimilar uptake.
FDA's Biosimilar Action Plan aims to boost approvals, but Commissioner Gottlieb says he's had a change of heart about how much impact an interchangeability designation can have on market uptake.
Advice document, little changed from a March 2016 draft, continues to reflect agency’s view that clinical studies supporting a demonstration of biosimilarity should not be included in labeling.
While industry awaits formal guidance ahead of March 2020 transition deadline for certain protein products, FDA's Christl says plan will take into account therapeutic equivalence ratings when deciding whether products are 'deemed' licensed as full biologic applications or biosimilars.
Siga is entitled to a $41m “hold back” payment under its contract with the Biomedical Advanced Research and Development Authority and potentially a $50m payment related to the US FDA's extended shelf-life determination for stockpiled Tpoxx; company also picks up first priority review voucher awarded for a medical countermeasure, which it likely will monetize.
Advisory committee questions about malaria drug’s breakthrough therapy and orphan drug designations reflect lingering confusion about how agency’s various regulatory pathways impact product development and approval.