Enbrel Biosimilar Market In Sandoz's Grasp; Will Cost, Litigation Derail It?
With the FDA giving an overwhelmingly positive review of Sandoz Inc.'s application for its biosimilar version of Enbrel (etanercept), which is sold in the US by Amgen Inc., the product appears to be headed to the US market – pending a likely blessing from the agency's advisory panel, which is meeting on July 13. But Sandoz must still get past litigation and convince prescribers and patients its etanercept biosimilar provides value over Enbrel.
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A three-judge panel from the US Court of Appeals for the Federal Circuit on July 5 ruled that the 180-day notice of commercial marketing applies to all biosimilar applicants, giving a win to Amgen over Apotex. But in its latest interpretation of the US biosimilars law, the court appears to suggest the FDA needs to establish a tentative-style approval approach for those products, similar to what's employed for generic drugs.
While an invitation for the top US government litigator to weigh in on Amgen Inc. v. Sandoz Inc. has prolonged the Supreme Court's decision on whether it will take up the case – creating a certain amount of limbo for the biosimilars marketplace – the request demonstrates the justices appear to be taking the matter seriously, upping the chances they may hear oral arguments potentially next spring.
For the second time, Novartis AG unit Sandoz Inc. is trying to "reap the commercial benefits" provided to biosimilar manufacturers under the Biologics Price Competition and Innovation Act (BPCIA), while seeking to avoid the obligations Congress established under the 2010 law "to protect innovators," Amgen Inc. and Roche AG charged in new court documents.