FDA Mostly Shoots Down BMS’ Petition to Halt Abraxane Generics

The FDA has mostly rejected the Celgene/Bristol Myers Squibb (BMS) petition to delay generic versions of its blockbuster chemotherapy drug Abraxane (paclitaxel) from hitting the market.

BMS’ subsidiary Celgene, which wasn’t yet owned by BMS when it filed a citizen petition with the FDA in 2015, asked the FDA to require makers of generics to jump through multiple hoops before allowing any of them to make and market an Abraxane generic.

Abraxane, which earned almost $1.25 billion for BMS in 2020, is used in treating metastatic breast cancer, locally advanced or metastatic nonsmall-cell lung cancer as first-line treatment in combination with carboplatin in patients who aren’t candidates for curative surgery or radiation therapy. It is also approved as a first-line treatment in combination with gemcitabine for metastatic adenocarcinoma of the pancreas.

The FDA shot down each of the requests in the petition, except a requested revision to draft guidance to clarify the definition of what are known as “free” and “bound” paclitaxel or albumin.