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Waxman-Hatch legislation

In the US, the Hatch-Waxman legislation has started the wheels turning with regard to biosimilar acceptance. The legislation that the FDA utilizes as its reference point is provision 505 (b) (2), which allows for the approval of different biological therapies when compared to the originator s product. Both the EU and the US are under increased pressure to approve biosimilar products as soon as possible. The basis of this reality cannot be understated. [Pg.1768]

In 1984, President Reagan signed into law the Drug Price Competition and Patent Term Restoration Act (Waxman Hatch Act). This legislation created a system... [Pg.3987]

See other pages where Waxman-Hatch legislation is mentioned: [Pg.13]    [Pg.53]    [Pg.249]    [Pg.13]    [Pg.53]    [Pg.249]    [Pg.12]    [Pg.17]    [Pg.127]    [Pg.100]    [Pg.43]    [Pg.190]    [Pg.52]    [Pg.1722]    [Pg.22]    [Pg.22]    [Pg.181]    [Pg.751]    [Pg.449]    [Pg.34]    [Pg.281]    [Pg.105]   
See also in sourсe #XX -- [ Pg.382 , Pg.383 , Pg.630 ]



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Hatch-Waxman

Hatching

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