The shape of biosimilar litigation for years to come will be on the line April 26 when the Supreme Court hears oral arguments in the Sandoz Inc. v. Amgen Inc. case. Depending on the decision, biosimilar sponsors could face protracted litigation and even launch delays, and with so much on the line, innovator companies, biosimilar applicants and other stakeholders filed a slew of amicus briefs.
Ringside For Zarxio At Supreme Court: Biosimilar Stakeholders Line Up
High court set to determine timing of biosimilar marketing and how parties handle patent disputes in Sandoz v. Amgen. Stakeholders say the outcome will impact innovation, access to biosimilars and future litigation.
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The development could highlight the power of competitive market forces over government price controls or suggest Medicare price negotiation is enhancing competitive market forces.
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Roche is in the crosshairs of the Belgian Competition Authority for allegedly delaying the entry of rituximab and trastuzumab biosimilars between 2017 and 2020, after the BCA sent the firm a statement of objections over “exclusionary practices.”
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Two recent disclosures from Xbrane Biopharma and Formycon demonstrate the evolving US Food and Drug Administration thinking about the need for Phase III trials to support biosimilar filings.
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Regulatory authorities from multiple regions are considering extending a pilot project related to collaborative assessments of post-approval chemistry, manufacturing and controls changes, with a focus on the supply of critical medicines.
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Teva was forced to delist its ProAir HFA inhaler patents from the FDA’s Orange Book by mid-March after the Federal Circuit denied its petition for en banc rehearing. Will the Supreme Court listen?
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The development could highlight the power of competitive market forces over government price controls or suggest Medicare price negotiation is enhancing competitive market forces.
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Multiple sources, including former Acting FDA Commissioner Janet Woodcock, told the Pink Sheet that industry is quietly complaining about FDA work delays and they expect the problem will worsen.