Posted by Michael Wonder on 19 Nov 2018
Novartis joins call asking FDA to stop biosimilar trash-talkers
17 November 2018 - Novartis has joined Pfizer in asking FDA to stop campaigns from branded drugmakers that the pharmas say are misleading the public about the safety of biosimilars.
Novartis submitted its comments in a letter made public 14 November in support of a Citizen’s Petition filed in August by Pfizer.
In the original petition, Pfizer requested FDA issue guidance outlining false or misleading sponsor communications to clarify what would be considered "inappropriate." The petition singled out companies it accused of creating "doubt about the safety and effectiveness of biosimilars," including the Genentech unit of Roche, the Amgen Biosimilars subsidiary of Amgen and the Janssen Biotech unit of Johnson & Johnson.
