[Ip-health] Generic/Follow-On Biologics - Care to Share Your Views?

[Biotech. Info. Inst.]

I am interested in learning the views of list members (and promoting
list discussion) concerning biogenerics, including the opinions of
many of the consumer, safety, patient and other advocates that
subscribe to this list.  Many groups and individuals usually very
vocal on topics involving pharmaceutical economics and safety seem to
be strangely quiet on this topic and related bills currently being
considered in Congress.

What is your view regarding the U.S. implementing a regulatory regime
for generic biopharmaceuticals, biogenerics, follow-on proteins/
biologics, or whatever you may call them?  This includes the current
bills in Congress to grant FDA authority for follow-on biologics,
i.e., giving FDA the ability to grant full approvals for biologics
based on abbreviated applications (often involving bioequivalence/
pharmacokinetic trials comparing the new product with an earlier
reference product, rather than full placebo-controlled Phase III-like
safety and efficacy trials), optionally with the ability to formally
designate therapeutic equivalency/substitution.

Stated very simplistically:  Biogeneric approvals favor economics,
notably cheaper versions of many of the most expensive
pharmaceuticals, but potentially at the risk of safety, e.g.,
difficulties in post-marketing surveillance, inappropriate
substitution/use of products that are not really equivalent/
substitutable, and mixing-up of similarly-named prescriptions by
physicians, pharmacies and patients, etc.  Keeping the status quo (no
generic biologics approvals; all products must be fully proven safe
and effective, not presumed safe and effective based on similarities/
comparisons to a prior product, and given their own unique name)
favors safety, easier tracking of prescriptions, less opportunities
for mix-ups, etc.  But, this eliminates much or even all of the
savings development as a generic offers (cheaper, faster, simpler
testing and applications, allowing lower price) and reduces/
eliminates incentives for biogenerics development and competition in
the marketplace.

Where do you stand?  [Again, stating things very simplistically].  Do
you support the innovator/established companies, many of which are
criticized for overly-expensive products, and supporters in claims
that safety should not be compromised, that full or extensive
clinical testing should be required for each biologic; or the claims
of some that generic biologics, both abbreviated approvals and,
particularly, therapeutic equivalency, are inherently impossible
(unsafe), due to the inherent inability for others to manufacture the
same complex biological product?  Do you view the innovator industry
"process = product" mantra as valid/true or bogus/a smoke screen?  Do
you take a pragmatic/economic approach, e.g., patient groups with
diseases treated with available biopharmaceuticals favor anything
that would facilitate cheaper generics, while patient groups with
diseases lacking adequate therapeutics are against biogenerics/follow-
ons, because they threaten innovation, incentives and development of
new, needed therapeutics?

For those with an interest in biogenerics, check out my embryonic Web
site at http://www.followonproteins.com, and the U.S. BIOPHARMACOPEIA
Registry of Biopharmaceutical Products Web site at http://
www.biopharmacopeia.com.  The former currently provides some basic
news and background.  The later concerns the underlying paradigms,
terminology, definitions and nomenclature for biopharmaceuticals and
biogenerics (which will largely control how these are perceived,
regulated and marketed).

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; www.biomanuf.com;
     www.biopharmacopeia.com; www.followonproteins.com