Tag Archive: biosimilar

May 01 2013

New Guidance: Formal FDA Meetings for Biosimilar Product Development

On 01 April 2013, the FDA released its fourth guidance regarding the development of biosimilar products: Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants.  Biosimilars are biological products that are demonstrated to be “highly similar” or “interchangeable” to an approved biological product.  The process for the approval of biosimilar products was …

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Aug 15 2012

FDASIA, Part 4: Drug Supply Chain, Drug Shortages, and Other Provisions

On 09 July 2012, the Food and Drug Administration Safety and Innovation Act (FDASIA, otherwise known as PDUFA V) was signed into law.  In a 4-part weekly series, we are covering the major changes in FDASIA as follows: Part 1: The “UFAs”: PDUFA, MDUFA, GDUFA, and BsUFA Part 2: Pediatric Drugs and Devices and Medical …

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Jul 20 2012

FDASIA, Part 1: The “UFAs”

On 09 July 2012, the Food and Drug Administration Safety and Innovation Act (FDASIA, otherwise known as PDUFA V) was signed into law.  In a 4-part series, we will cover the major changes in FDASIA as follows: Part 1: The “UFAs”: PDUFA, MDUFA, GDUFA, and BsUFA Part 2: Pediatric Drugs and Devices and Medical Device Regulatory …

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Jul 16 2012

New Provisions in the FDA Safety and Innovation Act (aka PDUFA V)

Seal of the U.S. Congress

On 09 July 2012, President Obama signed FDASIA (otherwise known as PDUFA V) into law. The reauthorization of PDUFA V has been working its way through both houses of Congress since May and has received uncharacteristically broad bipartisan and bicameral support. In 2007, PDUFA IV was hotly debated between the two chambers and was barely passed in time to replace the expiring PDUFA III, but this time, lawmakers were able to meet their goal of sending the President a reconciled bill well before the 30 September expiration date of PDUFA IV.

The new law will go into effect on 01 Oct 2012 and will sunset on 30 Sept 2017.

The FDASIA includes the following provisions

May 25 2012

PDUFA V: A Funny Sounding Name for a Very Important Bill (Updated!)

US Capitol

Can you say PDUFA (pŭ-dōō-fŭ)?  The United States Senate can.  A very partisan Senate showed uncharacteristically bipartisan support for the Prescription Drug and User Fee Act (PDUFA) V, voting on 24 May 2012 to reauthorize PDUFA by a 96 to 1 vote.  This reauthorization allows for a 6% increase in fees paid by drug and …

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Mar 09 2012

After all the talk, where are we with biosimilars?


In this highly charged political climate, no news broadcast is complete without some mention of healthcare.  Frequently the focus is on healthcare costs, which is one reason that the government charged the FDA in 2010 with creating the 351(k) approval process for biosimilars (generic versions of biologically manufactured products).  Well-known marketed biologics in the U.S. …

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Nov 29 2011

Fifth China Medicinal Biotech Forum – Conference Recap

I recently returned from the Fifth China Medicinal Biotech Forum held in Beijing, China from 07-09 November 2011.  The purpose of this conference was to update graduate students in China on the latest trends in biotechnology.  This forum also allowed scientists from Europe, Australia, Japan, US, and South America to collaborate with Chinese colleagues at …

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Jul 14 2011

Recap of the DIA Annual Meeting 2011

The 47th Annual DIA Meeting was held on 19-23 June 2011 in Chicago and was a great success with thousands of attendees from the health care industry and regulators from around the world including representatives from the FDA, the EMA, and many other global agencies. This year’s keynote speaker was the renowned AIDS researcher and …

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Sep 21 2010

Biomarker Qualification and Validation: Where are We Now?

Personalized medicine.  The pinnacle of healthcare where treatment for a patient’s disease is specifically tailored for his or her genetics and disease characteristics.  As the era of blockbuster drugs is drawing to a close, the era of personalized medicines is gushing in to fill the void.  One primary force driving the shift in healthcare and …

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Jul 27 2010

Generic Lovenox – Moving One Step Closer to Biosimilars

We bleed from similar veins. – Tupac Shakur Lovenox is not, I repeat, not a biologic therapeutic.  It is derived from a biological source (pig intestines, yum), but it is not protein-based.  However, the FDA’s approval of a generic form has a rather interesting bearing on the future of biosimilars. But first, the basics:  Lovenox …

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