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FDA's Biosimilars Guidance

The federal agency finally breaks out some information on what it might take to get generic biological drugs approved.

By | February 13, 2012

image: FDA's Biosimilars Guidance Flickr, Steven Depolo

FLICKR, STEVEN DEPOLO

The US Food and Drug Administration has unveiled its long-awaited draft guidelines on so-called "biosimilar" drugs, generics that mimic the action of biological drugs like enzymes and antibodies. Drugmakers have been anxiously anticipating guidance from the FDA as biologics patents expire and cheaper generic versions of biologics is a potentially huge market waiting to be tapped.

But in the three draft guidance documents, the FDA provided little specific information on what companies need to do to get biosimilars approved or on the "abbreviated approval pathway" mentioned in the Patient Protection and Affordable Care Act, signed into law by President Barack Obama in 2010. Instead, the agency indicated that it will instruct companies interested in developing such generics in specifics necessary to get their biosimilar products approved—like the size and types of clinical trials—on a case by case basis.

"I don't think [the FDA] gave much guidance," D'vorah Graeser, patent agent at Chicago and Israel-based law firm Graeser Associates International, told Nature. Companies launching into the biosimilars game "may be rejected and have to go back to the drawing board several times," she added.

But the FDA may eventually roll out more guidance documents, providing more details. "We're not sure," Rachel Sherman, director of the office of medical policy in the FDA's Center for Drug Evaluation of Research, said at a press conference last week. "At the moment we're trying to get the most bang for our buck and cover the most territory possible, and going crack-by-crack does not seem to be the way to do that."

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Comments

Avatar of: decarlo2

decarlo2

Posts: 1

February 13, 2012

At the most recent House committee meeting on Biosimilar User Fee Agreement this past week, major concerns were raised on behalf of the pharmaceutical companies regarding the establishment of a level playing field between U.S. and foreign manufacturers. 

Overall, based on the recently released guidelines, the FDA has failed to establish a level playing field for domestic and foreign companies.  As mentioned in this post, it seems the review process testing for biosimilars is arbitrary according to a case by case basis.  This leaves serious questions regarding a conflict of interests between different manufacturers and the subsequent review process. 

On an international level, no recommendations have been provided regarding the inspection and GMP variations between foreign and domestic manufacturers.  This is extremely fascinating given half of the entire committee hearing was devoted to this topic.  For a more thorough discussion of BUFA, please consult the link below:

http://bit.ly/A8ATby

Avatar of:

Posts: 0

February 13, 2012

At the most recent House committee meeting on Biosimilar User Fee Agreement this past week, major concerns were raised on behalf of the pharmaceutical companies regarding the establishment of a level playing field between U.S. and foreign manufacturers. 

Overall, based on the recently released guidelines, the FDA has failed to establish a level playing field for domestic and foreign companies.  As mentioned in this post, it seems the review process testing for biosimilars is arbitrary according to a case by case basis.  This leaves serious questions regarding a conflict of interests between different manufacturers and the subsequent review process. 

On an international level, no recommendations have been provided regarding the inspection and GMP variations between foreign and domestic manufacturers.  This is extremely fascinating given half of the entire committee hearing was devoted to this topic.  For a more thorough discussion of BUFA, please consult the link below:

http://bit.ly/A8ATby

Avatar of:

Posts: 0

February 13, 2012

At the most recent House committee meeting on Biosimilar User Fee Agreement this past week, major concerns were raised on behalf of the pharmaceutical companies regarding the establishment of a level playing field between U.S. and foreign manufacturers. 

Overall, based on the recently released guidelines, the FDA has failed to establish a level playing field for domestic and foreign companies.  As mentioned in this post, it seems the review process testing for biosimilars is arbitrary according to a case by case basis.  This leaves serious questions regarding a conflict of interests between different manufacturers and the subsequent review process. 

On an international level, no recommendations have been provided regarding the inspection and GMP variations between foreign and domestic manufacturers.  This is extremely fascinating given half of the entire committee hearing was devoted to this topic.  For a more thorough discussion of BUFA, please consult the link below:

http://bit.ly/A8ATby

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