Biotech Values

[DewDiligence]

FDA rejects ABBV’s CP on indication extrapolation for interchangeable FoBs:

http://www.bigmoleculewatch.com/2017/01/18/fda-denies-abbvies-citizen-petition-on-interchangeability/

The timing is not coincidence; from #msg-127018386, posted 12/5/16:

…my expectation is that the FDA will, in due course, reject the CP because what ABBV is asking for—forbidding extrapolation of approved indications for interchangeable FoBs—would render interchangeable status almost inconsequential from a business standpoint for FoBs of biologics with multiple indications.

The FDA is presumably waiting until it has issued formal guidelines on interchangeable FoBs, so it can refer to specific passages in these guidelines in the rejection of ABBV's CP.