Replies to post #106942 on Biotech Values

[biomaven0]

Why wouldn't AZN run a head-to-head study to try to differentiate FosD from patients who have yet to try anti-TNF therapy? Is AZN afraid of a poor outcome on this front?

Here's my best guess:

The population AZN is studying is a tougher one than the broader RA population, and so proving efficacy against a placebo will actually be harder than it would be in the general RA population. But these days the FDA is all about risk vs benefit, and so the safety bar is implicitly lower for patients with an unmet need. Their drug is not quite clean (the hypertension issue) and so they have elected to go for the tougher population with an unmet need.

Note that the anti-TNF biologics are not without their safety concerns too, but doctors are now used to them.

Peter

[jq1234]

What's the consensus timeframe for when these will start to hit the market?

I don't think there is consensus. Enbrel is the first one off patent in late 2012 I believe. It really depends on what final biosimilar pathway will be.

RIGL not only needs to worry about anti-TNF biologic, but also PFE's oral Tasocitinib.

Why wouldn't AZN run a head-to-head study to try to differentiate FosD from patients who have yet to try anti-TNF therapy?

Anti-TNF drugs are highly effective drugs. Going head to head against them is extremely risky move. Drug companies don't do that often until after the drugs are established already.