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Foreign-born BioBetters waterboarded at U.S. ports-of-entry by FDA longshoremen and fitted with Phase IV concrete boots !
A recent article in the New England Journal of Medicine written by FDA employees stated that the FDA may take a "fingerprint" approach to racially profiling biosimilar proteins to ensure genetic conformance with Aryan regulatory principles.
Thus meaning that more biochemically diverse and so-called "biosimilar" Rx mAbs (monoclonal antibodies) -- and so-called "BioBetters" of any protein class -- will face even more regulatory bio-equivalent waterboarding and autoclaving by FDA officials at American ports-of-entry.
Still, almost weekly we hear of another Mom & Pop biotech company from Timbuktu entering the biosimilars and biobetters field with a business plan that calls for exporting their putative "identical" bio-products to the U.S. market (or to European markets, whose regulatory agencies may follow the FDA's lead).
But common sense dictates that even Merck, Sandoz/Novartis, Teva and Samsung will be challenged by this inchoate and emerging segment of the biotech drug industry.
Read the epitaph of the biosimilars / biobetters field here:
"Is the FDA writing a recipe for the failure of biosimilars in the U.S.?"
August 8, 2011
By John Carroll of www.FierceBiotech.com
"Will FDA officials raise the regulatory bar on biosimilars so high they can't be competitive in the U.S.? Longtime researcher and clinical trial consultant Dr. Saurabh Aggarwal seems to think there's a very high risk of that."
...
http://www.fiercebiotech.com/story/fda-writing-recipe-failure-biosimilars-us/2011-08-08
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And here is the earlier related post on this group:
FDA confirms pursuit of “Biosimilars” will be a fool’s errand
Biosimilars industry trapped for 3 – 5 years at least in horrific FDA Hall of Mirrors !
“FDA sketches a complex instruction manual for biosimilars”
FierceBiotech.com -- 04 Aug 2011
“A group of top FDA regulators has penned an article in the New England Journal of Medicine intending to give drug developers a clearer picture of the agency's thinking on the "abbreviated pathway" lawmakers demanded for biosimilars. But anyone hoping for a simple instruction manual with crystal clear goals and relatively low-cost data demands will be sorely disappointed. The regulations for developing biosimilars will come with its own complex set of customized instructions, complete with demands on animal and human data and new ground rules for initial talks with regulators."
...
http://www.fiercebiotech.com/story/fda-sketches-complex-instruction-manual-biosimilars/2011-08-04?utm_medium=nl&utm_source=internal
Original article here:
http://www.nejm.org/doi/full/10.1056/NEJMp1107285
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Posted by:
David A. Palella
BIOSCIENCE VENTURES Inc.
San Diego, California
cell: 619-787-5767
email: dpalella@gmail.com
http://www.linkedin.com/in/davidpalella
web site: http://www.BSVpartners.com
blog: http://biobizdev.blogspot.com
& Group Founder:
Infectious Disease R&D and Business Network
http://www.linkedin.com/e/-ubgx8c-godydbie-43/vgh/3937807/
Japan Biotech / Biopharma Partnering Forum
http://www.linkedin.com/e/vgh/2857975/
Biotech / Pharma Business Development, Licensing & Dealmaking
http://www.linkedin.com/e/-ubgx8c-gp40f4dt-22/vgh/3964633/
& Co-founder:
Stem Cells & Regenerative Medicine
http://www.linkedin.com/e/vgh/3921448
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Across the globe, the biosimilars industry has been growing stupendously for the past few years. Increasing healthcare costs and rising aging population are driving the industry that is expected to evolve greatly from its current state. In our latest report, it has been estimated that the global biosimilars market will expand at a CAGR of around 52% during 2010-2015. As the governments and private players around the world are stepping into the industry, there are immense opportunities to cash in on.
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