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Approval of Biogenerics ?

By Leah     Mar 8, 2007 in Health
Exploring new ways to improve access and affordability for biologic products.
PCMA continues to believe that the best way to meet this challenge is to pass legislation creating a clear regulatory pathway to approve follow-on biologics, or "biogenerics." Because such a pathway exists for "small molecule" drugs, there is tremendous generic competition in that space, which leads to lower prices.
I have HAP, and they switched everything to generics. If there is a generic for it, we get that instead.
I don't feel this is a bad thing, I am sure they are the same thing.
The Food and Drug Administration (FDA), however, currently lacks a clear regulatory pathway to approve "biogenerics."
To address this, PCMA was recently joined by a number of influential consumer, employer, and insurer groups who endorsed the bi-partisan "Access to Life Saving Medicine Act of 2007" (ALSMA). PCMA believes that the ALSMA improves on the experiences of the European Union biogenerics model. This new legislation relies upon competition, not price controls, to drive down costs. It would also create a streamlined process empowering the FDA to employ its high safety standards to independently determine approval for these products.
PCMA is the national association representing America's pharmacy benefit managers (PBMs), which lower the cost of prescription drugs for more than 200 million Americans with coverage provided through Fortune 500 employers, health insurers, labor unions, and Medicare Part D.
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