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With the US Supreme Court set to decide the biosimilars dispute between Amgen and Sandoz, LSIPR examines the possible outcomes and implications for those in the industry.
There is a sense of tension and anxiety in the US biotech industry.
In April, the US Supreme Court held an oral hearing with Amgen and Sandoz. The two parties have fought a long battle over the interpretation of the Biologics Price Competition and Innovation Act (BPCIA).
The Supreme Court, which is set to make its decision in June, heard oral arguments on two questions. The first was whether a biosimilar applicant’s 180 days’ notice of commercial marketing is properly given only after its biosimilar product has been approved by the Food and Drug Administration (FDA).
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biosimilar, Amgen and Sandoz, US Supreme Court, , OMalley, aBLA, BPCIA, applicants, sponsors, biosimilars