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Oshkosh Corporation Message Board

delmur 4 posts  |  Last Activity: Mar 17, 2015 8:00 AM Member since: Jun 7, 1999
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  • delmur delmur Jan 12, 2015 7:08 PM Flag

    Conjecture I agree and said as much in my thread. Baseless and unlikely is your opinion. This is taken from the FDA site on Biosimilars

    The Patient Protection and Affordable Care Act (Affordable Care Act), signed into law by President Obama on March 23, 2010, amends the Public Health Service Act (PHS Act) to create an abbreviated licensure pathway for biological products that are demonstrated to be “biosimilar” to or “interchangeable” with an FDA-licensed biological product. This pathway is provided in the part of the law known as the Biologics Price Competition and Innovation Act (BPCI Act). Under the BPCI Act, a biological product may be demonstrated to be “biosimilar” if data show that, among other things, the product is “highly similar” to an already-approved biological product.

    Health care professionals and consumers can be assured that FDA will require licensed biosimilar and interchangeable biological products to meet the Agency’s exacting standards of safety and efficacy.

  • delmur delmur Jan 12, 2015 5:57 PM Flag

    i'm sorry but I still find it troubling and very ironic that the FDA chose to do this at the very same time that TKMR and Oncore merges for only one disease, HBV. It just seems like imho that politics and influence were used here to get the FDA to slow down ARWR's progress so they can catch up. That and the fact that ARWR chose to go outside the FDA to do their studies first, and for good reasons I thought. Unfortunately it looks like Anzalone thought he could get it through FDA faster by doing it this way, and I thought it would be getting fast tracked soon myself.
    This disease is not as prevalent in the US as in ASIA, so FDA has an excuse to delay. I think it's good that ARWR is continuing on in Europe and Asia and I hope they embarrass the FDA, who has been saying in recent moths that they want to start getting new drugs out to the public faster. I just am confused by what happened today.

  • delmur delmur Jan 12, 2015 12:22 PM Flag

    I'm wondering if FDA is sticking it to ARWR because they went to Europe and Asia first to do the testing....seems to me like they want to slow them down for some reason.

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