Biosimilars Exclusivity Tug-of-War Brewing In The Mail; Can A Letter Add Eight Years To Reviews?
Executive Summary
Rising concerns among generic firms about how FDA will interpret biosimilar exclusivity provisions may have escalated due to fears about the consequences of increased congressional scrutiny of the new pathway.
You may also be interested in...
Naming Rights: Biosimilar Influence Efforts Continue Before Products Take The Field
FDA isn’t immune to political pressure, but a group of senators arguing that biosimilars should be given the same International Nonproprietary Name as their branded counterparts will need to make a stronger case than citing the agency’s own previous analysis.
Trans-Pacific Trade Agreement: GPhA, NGOs Oppose Proposed IP Provisions
As the U.S. enters the eighth round of negotiations over the Trans-Pacific Partnership Agreement, non-government organizations and the generic drug industry are speaking out against intellectual property proposals backed by brand-name pharma
Trans-Pacific Trade Agreement: GPhA, NGOs Oppose Proposed IP Provisions
As the U.S. enters the eighth round of negotiations over the Trans-Pacific Partnership Agreement, non-government organizations and the generic drug industry are speaking out against intellectual property proposals backed by brand-name pharma.