Replies to post #59253 on Biotech Values

[DewDiligence]

>Is this immune issue likely to be general question in the FoB space?<

Yes, IMO.

>I known that technically heparins are not biologics, but that seams more like government nonsense to me than science<

The difference is significant from a scientific standpoint. Heparins, being sugars, have a much lower potential for immunogenicity than most protein drugs.

>…could MNTA get a nice advantage in the FoB space by both getting a better understanding of the FDA requests, and also by pushing their views on achieving biosimilar status?<

The answer to the first question is Yes (IMO). I’m not sure exactly what you are asking in the second question; if your question is about the form of the coming FoB regs, the answer is that MNTA has indeed worked with both Congress and the FDA.