Replies to post #46633 on Biotech Values

[DewDiligence]

You’re warm, but that’s not exactly the answer to the question.

The FDA already has the authority to approve generic polysaccharide drugs (e.g. Lovenox) and generic polypeptide drugs (e.g. Copaxone) because these classes of drugs are regulated as small molecules.

[dewophile]

"...generic biotech/follow on biologics/pick-a-name drugs approved"

not to nitpick, and I am sure you are aware of this, but I think it is important not to lump generic biologics and follow on biologics together. generics imply non-inferiority to current standards. "follow-on biologics" represent an improvement to current agents. the former will be an attempt to rein in drug costs..the latter will surely be an attempt to do just the opposite and maintain premiums (which of course may be justified if there is significant value added clinically). Lastly, while some companies may have platforms for both, they are certainly mutually exclusive from a manufacturing, regulatory, and investment perspective