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Regulatory NEWS
While the patent challenge that's delaying the launch of the first biosimilar approved in the U.S. is grabbing headlines, some lawmakers may be second-guessing the final act of the Biologics Price Competition and Innovation Act (BPCIA).
Questioning the FDA's authority to issue a rule that would ultimately put generic drugmakers on the legal hook for "failure-to-warn" claims, several brand and generic companies urged the agency Friday to consider their alternative, which would make the FDA responsible for drug labeling changes once there's generic competition.
The U.S. Supreme Court will hear arguments March 31 in the case of Kimble v. Marvel, a case that tackles the issue of whether royalties necessarily expire when the underlying patent expires.
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