Sandoz’s Enbrel Biosimilar Filing May Spur New Litigation
This article was originally published in The Pink Sheet Daily
Etanercept biosimilar could face more complications on both patent and review front than Zarxio experienced.
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Amgen’s patent may keep Enbrel biosimilars off the market until at least 2028. Other biosimilar sponsors could face similar submarine patents that derail their commercialization plans.
Justices cite changing circumstances, constitutional concerns in preventing government from seeking dismissal of a case in which it initially declined to intervene. They also question whether government should intervene before moving to dismiss.
President Biden and Congress are pressuring the agencies to change patent policies so brand manufacturers cannot delay generic and biosimilar competition to keep monopoly prices. Timeline shows how they have responded to these demands.