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by spondylosaurus 847 days ago
To be fair, Xolair isn't a new drug at all (it's been around for 20-ish years, I think?), this is just a new thing that it's approved for.

I'm not sure why a generic hasn't hit the market yet, though. Maybe there's not enough demand to make it lucrative enough, unlike the golden child adalimumab...

3 comments

IIRC, MABs aren't really a thing, because unlike small molecules, part of the approval is for the whole biological pipeline to produce the antibodies, from cell line to chromatography to formulation. When a small molecule goes off patent, you just have to prove to the FDA you can make that molecule to sufficient purity.

That's not to say there are no generic MABs, it's that it is a far costlier process for the generic manufacturers to get up and running.

I have seen a lot of generics for TNF inhibitors MABs, but that might just be because there's soooo much demand for those drugs. (Humira was one of the most profitable drugs of all time, after all.) Right now I'm on an infliximab biosimilar!
I wasn’t aware of this, thanks for clarification. I will leave my comment as-is because it’s my take on the general “we need to ban price gouging on new drugs!” sentiment.
Ha, I certainly agree about the price gouging! I've stayed at jobs I hated just to keep my health insurance (and therefore my meds) :P
What's the Mexican name? Asking for a Mexican friend.
Generic name for Xolair is omalizumab.