On The Trail Of Biosimilar Disclosure Scofflaws: FTC To Watch For Anti-Competitive Issues

As FDA prepares for another public hearing on the pathway, FTC says the rules requiring biosimilar applicants to share information with their reference product competitors could lead to anti-competitive issues and may be an ongoing concern.

Ensuring the security of a biosimilar sponsor’s data package when it is disclosed to the reference product’s owner is among the Federal Trade Commission’s most significant areas of concern once applications begin arriving at FDA, a commission lawyer said.

Prior to the pathway fully opening, however, innovator and potential biosimilar sponsors are hoping to get more answers to questions...