The US FDA should require postmarketing data on what happens when interchangeable biosimilars to the same reference product are substituted for each other, Janssen Biotech Inc. said at a Sept. 4 hearing on promoting competition and innovation in the biologics market.
Prospect Of Biosimilar-To-Biosimilar Switching Spurs Call For Postmarketing Data
US FDA questions innovator push of data to instill confidence that pharmacy-level switching between biosimilars interchangeable with same reference biologic; Janssen and others say agency needs to educate prescribers and pharmacists that an interchangeability designation applies only to a biosimilar and its reference product.
