FDA Request For Comments on "Approval Pathway for Biosimilar and Interchangeable Biological Products" - EuropaBio and EBE Comments


•The two associations believe that, if certain fundamental principles are maintained, and innovator rights fully respected, the FDA can develop a considered approach to the approval of safe and effective similar biological medicinal  products (“biosimilars”) that will provide additional treatment options to patients and healthcare professionals. 

• In this document EuropaBio and EBE focus on the regulatory experience of biosimilar legislation evolution and experience of these biosimilar products within the European Union (“EU”). Both associations have been, and continue to be, deeply involved in this process, and it is on the back of our experiences with the EU system that we humbly submit our input for the FDA consultation. 
• A specific biosimilar legislation was established  in the EU in 2004 and initial biosimilar guidance issued in 2005.  
• The EU biosimilar legislation and guidance has provided confidence in a robust regulatory process to appropriately evaluate and control biosimilars for prescribers and patients.  
• The availability of a biosimilar approval pathway  has resulted in the successful launch of 7 biosimilars molecules, marketed by 9 different biosimilar companies, under 14 different trade/invented names.