Avid Bioservices Inc (CDMO)

[mskatiescarletohara]

If a company has to run a whole new set of large clinical trials to get a generic drug approved, it won't be cheap.

Biowatch, you present some excellent observations regarding biogenerics and what their potential for success in the next few decades might entail. I, too, have wondered 'how' a generic company would be able to generate a generic mab without having to create their own cell line. Surely, the FDA would require and certainly demand clinical trials, and I doubt folks like DNA, PDLI, MEDX, ABGX, Lonza etc would hand over their cell cultures to a competitor. Sounds like an extremely risky venture to me, and I am not sure if there would be any lucrative incentives for biogeneric companies to take on such a venture. Sounds like a legal nightmare, and perhaps clinical nightmare. I agree with the author's take on AMGEN, ROCHE, DNA and other big powerhouse pharmas tying the generic competitors hands in patent litigation. Wonder if AMGN, DNA will start lobbying against any reforms the FDA may consider for assisting biogeneric's expedient entry to market?

McClellan showed sympathy for that argument, but also said generic biologics should be evaluated individually, depending on the complexity of the particular protein.

"I don't know that there will be any one general answer that will be applicable to all products. Some biologics are more complex than others ... I don't think there will be a universal answer," he said

Yes, I believe mabs which target specific targets are complex. Can't wait to see who heads up the new panel specifically created to address which mabs are complex and which ones are not. Just another headache brewing, no pun intended.

Ironic, IMCL is dealing with bioequivalence issues right now between the BB plant and Lonza, and yet the potential of screening biogenerics may not 'have' to be so thorough.


katie....