Replies to post #208181 on Biotech Values

[DewDiligence]

Re: Interchangeable FoBs /indication extrapolation

The FDA has not barred indication extrapolation for interchangeable FoBs, as evidenced by the rejection of ABBV’s Citizen Petition, which is directly on-point (#msg-127947222).

Note that in the write-up you posted, the text about indication extrapolation is not a direct quotation from the guidance document.