Search Results for patent dance

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US Supreme Court: No Six-Month Wait for Biosimilars After FDA Approval By Zachary Brennan - Published 12 June 2017

The US Supreme Court on Monday ruled unanimously that biosimilar companies will not have to wait an additional six months after US Food and Drug Administration (FDA) approval before launching their new biosimilars.

Categories: News, US, DOJ, FDA, Biologics and biotechnology, Business and Leadership, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: Supreme Court of the United States, SCOTUS, biosimilars, patent dance

US Supreme Court to Review Biosimilar ‘Patent Dance’ By Zachary Brennan - Published 13 January 2017

The US Supreme Court on Friday said that it will review whether biosimilar companies should have to wait six months after US Food and Drug Administration (FDA) approval before launching their follow-on products.

Categories: News, US, FDA, Biologics and biotechnology, Compliance, Due Diligence, Government affairs

Tags: SCOTUS, John Roberts, biosimilar patent dance, biosimilars and SCOTUS

Regulatory Explainer: Everything You Need to Know About Biosimilars By Zachary Brennan - Published 10 August 2016

For more than a decade now, biotech and pharmaceutical companies have brought a new class of treatments – biosimilars – to markets around the world (from the EU to India to South Korea to the US), offering cost savings for some of the most expensive medicines, though even in 2016, decades after companies began their quest to develop biosimilars, they are still only just beginning to see widespread adoption.

Categories: News, Africa, Asia, Europe, US, CDSCO, EMA, FDA, FTC, Health Canada, MHRA, Biologics and biotechnology, Government affairs, Manufacturing, Quality, Regulatory intelligence, Regulatory strategy, Research and development, Submission and registration

Tags: biosimilars, BPCIA, patent dance, biologics, biosimilar savings

Biosimilar ‘Patent Dance’: Federal Circuit Rules 180-Day Notice is Mandatory By Zachary Brennan - Published 05 July 2016

The US Court of Appeals for the Federal Circuit on Tuesday affirmed a district court’s ruling that a biosimilar applicant must provide a reference product sponsor with 180 days’ notice before commercial marketing of a biosimilar begins, regardless of whether the applicant provided notice of US Food and Drug Administration (FDA) review.

Categories: News, US, FDA, Biologics and biotechnology, Government affairs, Research and development

Tags: biosimilar patent dance, Apotex, Amgen, Federal Circuit