Is Fairness in the Eye of the Beholder? Pfizer Citizen Petition Looking for Fair and Level Playing Field Between Biologics and Biosimilars

By Sara W. Koblitz — An interesting Citizen Petition popped up earlier this week in which pharma giant Pfizer has requested FDA guidance on sponsor communications about biosimilar products.  This is not a new campaign for Pfizer, who has emphasized the need to address anticompetitive exclusionary practices, “misinformation,” and market access issues with respect to biosimilars for at least the last year. Pointing to the same anticompetitive behavior that FDA Commissioner Gottlieb has admonished recently in both the biosimilar and the generic space, Pfizer raises concerns that the lack of market confidence in biosimilars resulting from the proliferation of false and misleading information by reference product sponsors has stymied market acceptance and uptake. We’re used to seeing big pharma companies on the other side of these types of petitions – brand name sponsors are more often accused of exclusionary behavior than attempting to combat it.…

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