[Ip-health] Biopharmaceutical Product FDA Approvals Study Published

[Biotech. Info. Inst.]

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I've just published an article in Genetic Engineering and
Biotechnology News (GEN) regarding recent trends in FDA approvals of
biopharmaceutical products.  See http://www.biopharma.com/approvals1.html
  for this and the associated running list of approvals at http://www.biopharma.com/approvals.html
.

  Major findings included:
FDA approvals of biopharmaceutical products have decreased in recent
years. This includes recombinant proteins and monoclonal antibodies
and cancer therapeutics.
In the decade 1996-2005, there were an average of 16.6 approvals/year,
while there were only 12 and 11 approvals in 2006 and 2007,
respectively.
2007 was a particularly unproductive year. Besides a low level of
novelty (with many products similar to prior products), all of the
2007 approvals combined are projected to have less than blockbuster
($1 billion/year) sales (not counting Mircera, which is barred from
marketing due to patents), and none will significantly improve
healthcare for large numbers of patients.  Only two recombinant
proteins were approved in 2007, a level more typical of the 1980s.
The low numbers of approvals in recent years are of particular
concern, because a large number of products have been in the
development pipeline.
It is unclear why approvals have decreased and who, if anyone (FDA and/
or industry), deserves the blame for this.
Filings for a number of products are pending or expected. So, major
increases in approvals are likely in 2008 and 2009.
If biopharmaceutical approvals, their novelty and heathcare and
economic impact remain at recent and, particularly, 2007 levels, the
industry is headed for serious problems, potentially even economic
collapse.

Thank you.

Ronald A. Rader
President / Author:  Biopharmaceutical Products in the U.S. and
European Markets
Biotechnology Information Institute
1700 Rockville Pike, Suite 400
Rockville, MD 20852
Phone:  301-424-0255
E-mail:  ron@biopharma.com
Web sites:  www.biopharma.com; www.bioinfo.com