Genentech explains Avastin distribution changes
by David Williams
I interviewed Genentech spokeswoman Dawn Kalmar today to get some more details on the company’s decision to stop distributing Avastin to compounding pharmacies. For background please see my prior posts: Avastin update: Still seeking answers and Latest developments in the Avastin/Lucentis saga raise new questions.
In summary:
- In its inspection of Genentech’s manufacturing site, FDA objected to the level of particulates in Avastin, holding Genentech to the higher ocular standard rather than the intravenous standard
- Genentech is hopeful that it won’t have to make Avastin to the ocular standard on an ongoing basis, but isn’t certain
- Genentech doesn’t know who filed the complaint against New England Compounding Center that led to a Warning Letter against that compounding pharmacy for repackaging Avastin
- Genentech seems unlikely to seek FDA approval to continue supplying Avastin to compounding pharmacies
In my view, this isn’t turning out too well for Genentech.
- Avastin repackaging will continue to stunt Lucentis sales
- FDA may force Genentech to make Avastin to ocular standards on an ongoing basis
- Ophthalmologists are unhappy with Genentech rather than grateful to it for the efficacy of Lucentis
For a transcript of the interview, please visit the Health Business Blog
