Biosimilars Podcast: What To Expect When Supreme Court Hears Amgen vs. Sandoz
Pink Sheet's Brenda Sandburg talks to Prevision Policy’s Kate Rawson about who has the most at stake in the case, the questions she’ll be listening for during oral arguments, and what might be in store from the newest addition to the Supreme Court: Justice Neil Gorsuch.
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High court set to determine timing of biosimilar marketing and how parties handle patent disputes in Sandoz v. Amgen. Stakeholders say the outcome will impact innovation, access to biosimilars and future litigation.
Rep. Matsui withdrew amendment on FDA’s use of patient experience data during health subcommittee markup of user fee reauthorization legislation, but it may be considered in full committee markup following agency input. Chair Eshoo says the provision specifying contrast agents must be regulated as drugs needs to be reworked to include ophthalmic products.
Peter Marks says agency will proceed to meeting once Pfizer and/or Moderna complete their submissions and that the two may be considered at the same VRBPAC panel. FDA's effectiveness standard has not changed, CBER director says, but acknowledges that vaccines might be a little less effective than 50% in subpopulations.