No Generic biologics in FDA legislation
Reuters is reporting that the new FDA legislation is unlikely to have any biogenerics in it.
UPDATE 1-Lawmakers: Generic biologics unlikely in FDA bill | Health | Reuters
I personally think there should be something at least giving a timeframe on when the FDA should have to present a report to Congress on how and when they will implement some kind of program.
Here is the key from my perspective.
The chances of adding the generic biologics measure to a broad FDA bill now moving through Congress are “extremely slim,” Rep. Henry Waxman, a California Democrat, told a Generic Pharmaceutical Association conference.
I realize that biologics are not like standard drugs in terms of generics but really think that until Congress demands that the FDA come up with some sort of plan, nothing will move forward. It is too bad that Europe will be the one taking the forefront in this movement. As an example, EMEA just approved a follow-on for EPO for Sandoz, Novartis’ generics division.
Sandoz Receives European Commission Approval for biosimilar epoetin alfa
I know there will be a lot of lobbying of Congress on this issue but think that regardless there needs to be some sort of plan put forward. Just trying to delay and avoid the issue is only going to cause more public relations problems for biotech in the future.
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Technorati Tags: biogenerics, biosimilars, FDA, follow-on biologics
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