Wed, Sep 17, 2014, 6:17 PM EDT - U.S. Markets closed

Recent

% | $
Quotes you view appear here for quick access.

Momenta Pharmaceuticals Inc. Message Board

  • riffissimo riffissimo Feb 9, 2012 1:20 PM Flag

    FDA BioGeneric Guidelines - Key Section

    Q. I.14. Can an applicant obtain a determination of interchangeability between its proposed product and the reference product in an original 351(k) application?
    A. I.14. (Proposed Answer): Yes. Under the BPCI Act, FDA can make a determination of interchangeability in a 351(k) application or any supplement to a 351(k) application. An interchangeable product must be shown to be biosimilar to the reference product and meet the other standards described in section 351(k)(4) of the PHS Act. At this time, it would be difficult as a scientific matter for a prospective biosimilar applicant to establish interchangeability in an original 351(k) application given the statutory standard for interchangeability and the sequential nature of that assessment. FDA is continuing to consider the type of information sufficient to enable FDA to determine that a biological product is interchangeable with the reference product.

    Takeaway...

    This should say, "FDA and MNTA (alone) are continuing to consider the type of information sufficient to enable FDA to determine that a biological product is interchangeable with the reference product. Let's see what MNTA invents."

    SortNewest  |  Oldest  |  Most Replied Expand all replies
 
MNTA
11.40+0.32(+2.89%)Sep 17 3:59 PMEDT

Trending Tickers

i
Trending Tickers features significant U.S. stocks showing the most dramatic increase in user interest in Yahoo Finance in the previous hour over historic norms. The list is limited to those equities which trade at least 100,000 shares on an average day and have a market cap of more than $300 million.