Why we need to lower U.S. regulatory barriers around biosimilar approvals now
The FDA’s internal review on Amgen’s biosimilar of Humira reads like a product endorsement. Posted on Friday, the agency insiders essentially said: Let’s give it a quick kiss on both cheeks and approve this knockoff. It’s good to go on every indication AbbVie has in the U.S., which is the lynchpin to its global, $14 billion franchise.
The legal war still has to play out, but the real lesson here is that now that the applications are coming, the agency experts are having no trouble recommending a green light to these biologic twins. The data packages they’re delivering are decisive. And years of watching lawmakers and regulators play a tug-of-war over the rules around biosimilar development have come down to this:
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