Biotech Values

[floblu14]

This development is still likely a few years away....

Craig Wheeler:
The key meeting for us is what's called the "type 3" meeting, in which the FDA will accept your data package on physiochemical and biologic characterization as well as your process -- all the nonclinical things. And they will review it within 120 days, and then you'll have a meeting. And at that meeting they will give you guidance in terms of what kind of clinical trials are required and the potential for interchangeability.

[But] for us, we're trying to get interchangeability out of the blocks, and hopefully set the standard for the FDA and actually get those advantaged approvals [such as a proposed 180-day exclusivity window, or even de facto exclusivity for a branded biologic's first approved biosimilar]. If we can succeed with that, this is going to be a tough market for a lot of people who aren't interchangeable.

Assuming Congress ratifies the draft guidelines, how quickly could you bring biosimilars to the market?
It depends on how the FDA pathway evolves. If we go in and take advantage of this pathway and the type 3 meeting, and the FDA agrees with us that we don't have to do major Phase 3 trials, it could be relatively quick. If they're not quite ready to do that, and we have to do full trials, then it's going to take a little while because we're going to have to execute the full set of trials.

In terms of taking advantage of the pathway, I would hope once the pathway is fully up and running that would be a less-than-12-month process. But I don't expect it to be that way out of the blocks. This is brand new for the FDA; they're just staffing it up. It's going to be slower, so I'm kind of thinking it will be more in that 18- to 24-month range.

I hope it's much quicker, but I am also a realist. I have been burned many times before.

http://www.thedeal.com/magazine/ID/045648/dealmakers/movers-shakers-a-qa-with-momentas-craig-wheeler.php#ixzz1qhzLeZMh