AbbVie Seeks Strict Interchangeability Standards For Biosimilars
This article was originally published in The Pink Sheet Daily
Executive Summary
Interchangeability must be demonstrated for every indication on reference product's label even if biosimilar is not approved for all the same uses, AbbVie says in citizen petition filed three weeks after Amgen submitted a 351(k) application referencing Humira.
You may also be interested in...
Biosimilar Litigation: Genentech Avastin Suit Tossed; Janssen Remicade Case Uncertain
US court dismisses Genentech suit over Amgen's patent dance moves; Janssen v. Celltrion trial is postponed as parties fight over Janssen's standing to sue; and Amgen wants to bar AbbVie citizen petition filers from seeing its Amjevita information.
Biosimilar Litigation: Genentech Avastin Suit Tossed; Janssen Remicade Case Uncertain
US court dismisses Genentech suit over Amgen's patent dance moves; Janssen v. Celltrion trial is postponed as parties fight over Janssen's standing to sue; and Amgen wants to bar AbbVie citizen petition filers from seeing its Amjevita information.
Biosimilar Labeling: Should FDA Just Throw Up Its Hands And Finalize Guidance?
Brand and generic industries are on opposite sides of spectrum on most issues; there is mutual opposition, however, to the use of a meaningless four-letter suffix in the proper name of a product.