FDA Eases Way For Gold-Standard Biosimilars

Law360 (May 10, 2019, 9:13 PM EDT) -- The U.S. Food and Drug Administration on Friday cemented its criteria for approving cream-of-the-crop biosimilars that pharmacies can automatically substitute in place of pricier biologics, simplifying standards it previously proposed and handing a badly needed win to the struggling biosimilars industry.

In final guidance, the FDA outlined its key considerations for deeming a biosimilar "interchangeable" with an innovator biologic. That's the gold standard to which all biosimilars aspire so they can be substituted at the pharmacy counter without a doctor's permission, just like traditional generic drugs.

"With this final guidance, I think we are closer to seeing the first interchangeable product out...

Stay ahead of the curve

In the legal profession, information is the key to success. You have to know what’s happening with clients, competitors, practice areas, and industries. Law360 provides the intelligence you need to remain an expert and beat the competition.

  • Access to case data within articles (numbers, filings, courts, nature of suit, and more.)
  • Access to attached documents such as briefs, petitions, complaints, decisions, motions, etc.
  • Create custom alerts for specific article and case topics and so much more!