UNS unilife corporation

why biotechs need to worry about generics, too, page-3

  1. 750 Posts.

    "You take that biologic you originally had, you change the structure, [and] you get a new product."

    Hate to rain on your parade, but altering the device which
    delivers the biologic is not the same as altering the
    structure of the Biologic itself.

    If you think that putting the same drug into a Unifill
    device will extend the patent life of a biologic by another
    12 years then I believe you have misunderstood the
    purpose of this new legislation.
    A change in the Biologic itself that improves safety, eg.
    less side-effects, is grounds for applying for a new or
    supplemental DLA, but I can't see the FDA granting one
    just because the delivery mechanism has changed.

 
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