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

The Drug Quality & Security Act – Impact Will Take Time

Posted by John Kouten, CEO

Mar 28, 2014 3:30:00 PM

On November 27, 2013, President Obama signed into law the Drug Quality and Security Act.  This law is updates the federal drug tracing and tracking system and outlines Federal Drug Administration (FDA) authority over compounding pharmacies.

In 2012, a large outbreak of meningitis was linked to unsanitary conditions at a compounding pharmacy.  Historically, the FDA had limited authority over compounding pharmacies, leaving oversight of the pharmacy to the states.

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Topics: drug development, FDA

Life Sciences Industry - Not Hopeless

Posted by John Kouten, CEO

Mar 22, 2012 11:23:00 AM

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Topics: US pharmaceutical market, drug development, FDA, clinical trials

The JFK Download: FDA & Social Media

Posted by Michele Beyer

Jan 20, 2012 5:20:00 PM

Welcome to The JFK Download - JFK Communications' video blog. This inaugural edition of The JFK Download, David Patti, Senior Vice President, JFK Communications, discusses the latest FDA Guidance, "Responding to to Unsolicited Requests for Off-label Information About Prescription Drugs and Medical Devices," and what implications this guidance has on the healthcare communications industry.

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Topics: Healthcare communications, pharmaceutical, FDA, JFK Communications, Social media in pharma marketing, impact of social media in healthcare

Life Sciences and Social Media: Learning to Live Together

Posted by John Kouten, CEO

Oct 19, 2011 4:39:00 PM

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Topics: Healthcare communications, pharmaceutical, FDA, Social media in pharma marketing

Outsourced Manufacturing Partners Provide Expertise, Capacity, Speed

Posted by John Kouten, CEO

Jul 20, 2011 4:34:00 PM

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Topics: US pharmaceutical market, drug development, pharmaceutical, FDA, contract manufacturing

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

 

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