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by kortex 843 days ago
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.

1 comments

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!