Science is Beautiful Blog

Biosimilars in the U.S.– A Myriad of Stakeholders Will Continue to Frame This Important Issue in 2015

Posted by John Kouten, CEO

Jan 12, 2015 7:03:57 PM

Ever since the Biologics and Price Competition and Innovation Act (BPCIA) of 2009 found its way into the Affordable Care Act, various stakeholders have been preparing for the U.S. introduction of these so-called “biosimilars.”

Novartis/Sandoz announced in July 2014 that EP2006 was the first 351(k) application accepted for review by US Food and Drug Administration (FDA), an event that occurred almost four and a half years after passage of the BPCIA.  And on January 7, 2015 the FDA Oncologic Drugs Advisory Committee (ODAC) recommended approval of Novartis/Sandoz’ investigational biosimilar filgrastim in the US. The Committee also recommended approval of the biosimilar for use in all indications included in the referenced product’s (Amgen’s NEUPOGEN®) label.

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Topics: FDA, healthcare reform, biosimilars

FY 2012 Budgets takes Aim at Patent Exclusivity for Biologics

Posted by John Kouten, CEO

Feb 23, 2011 5:48:00 PM

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Topics: US pharmaceutical market, biotechnology and medical technology companies, drug development, biosimilars, patent exclusivity

FDA Speak: Complex Molecules Are Not Biologics

Posted by John Kouten, CEO

Jul 26, 2010 2:47:00 PM

Could the recent FDA approval of a generic version of Lovenox (enoxaparin) be the beginning of approvals of other complex molecules?  We recall that the Biologics Price Competition and Innovation Act of 2009 found its way into the Health reform bill.  The Biologics Act provides a pathway for biosimilars, however, grants biologics innovator companies 12-years patent exclusivity (http://tiny.cc/ymnj1).   While biologics currently reside outside the current generics approval processes, it seems that “complex molecules” like enoxaparin do not.  The developers of the generic enoxaparin, Sandoz, division of Novartis, are hoping to win approval next for a generic version of the “complex mixture” Copaxone for the treatment of multiple sclerosis.  For more details on FDA’s position visit: http://tiny.cc/fvvve.  For more information regarding Sanofi’s position, read their July 23 statement here:  http://tiny.cc/zgib3.

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Topics: biotechnology and medical technology companies, FDA, JFK Communications, biosimilars

Biosimilars: High on Obama’s Agenda

Posted by John Kouten, CEO

Jun 19, 2009 4:39:00 PM

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Topics: US pharmaceutical market, biotechnology and medical technology companies, biosimilars

 

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