Replies to post #8825 on Momenta Pharmaceuticals, Inc. (MNTA)

[DewDiligence]

Thanks, floblu. I was expecting a typical puff piece, but this interview actually has some meat on the bones. Regards, Dew

[iwfal]

Wheeler:

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.

The whole rest of the article made sense and put pieces together - but this is bizarrely optimistic. Lovenox and Copaxone took 6 years or so - 4 years longer than typical. Why would anyone assume that this will take less extra time here - when the problem is just as politically risky for the FDA and scientifically of the same order of complexity?

[stockbettor]

Assuming Congress ratifies the draft guidelines, how quickly could you bring biosimilars to the market?

I am not aware of any requirement that Congress must ratify the FDA's guidelines. I assume this is an erroneous statement by the interviewer. However, the new pathway for biosimliars was enacted as part of Obamacare. If the Supremes declare all of Obamacare unconstitutional, does that mean the FDA will stop working on the accelerated pathway. I hope not, but I also suppose Congress will then have to re-enact the biosimilar provisions before the FDA can make effective its rules to implement the pathway. It's anybody's guess as to when a future Congress might act on broad healthcare legislation. Given potential budget savings, biosimilars legislation might have a chance as stand-alone legislation.

FWIW, the comment period for the Q&As the FDA proposed in February ends on April 16th. I doubt that the FDA would require much time to issue final Q&As after the receipt of comments, but whether it will beat the Obamacare decision (expected at the end of June) is questionable.

http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm259797.htm