Biotech Values

[DewDiligence]

Re: ABBV’s CP on indication extrapolation for interchangeable FoBs

The FDA has taken no final action yet on the CP (http://www.bigmoleculewatch.com/wp-content/uploads/2016/11/Interim_Response_Letter_from_FDA_CDER_to_AbbVie_Inc.pdf ). However, 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.

Feedback welcome.