[Ip-health] Re: [Ip-health] Congress Should Not Adopt “No Generics” Proposals for Biologics: Evergreen ing and the Creation of Perpetual Marketing Mon opolies

[Biotech. Info. Inst.]

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On Jul 29, 2009, at 9:38 AM, Sarah Rimmington wrote:

> Even more worrisome, the HELP and Eshoo-Barton proposals would permit
> brand-name companies to pursue "evergreening" strategies that would
> enable them to obtain sequential 12-year marketing monopolies on
> biologics.

 From what I've seen, all proposed legislation including any data
exclusivity provisions, including that of Waxman, is fully gameable or
susceptible to perpetual evergreening.  Data exclusivity is
simplistically granted to products receiving full BLA approvals.  Much
as with generic drugs, the funny business, evergreening, etc. occurs
with the reference (innovator) products, not generics (or biosimilars)
approvals, and everyone seems to be happy ignoring defining criteria
for these products.

BLAs/approvals have negligible or no relationship to innovation, money
and effort invested in development, lack of patent coverage, whether
active agents and finished products are new/different, or whatever
reasons are cited as supporting data exclusivity for reference
products.  Full BLAs can be obtained for biologics simply by making a
change (just about anything) in a product, its manufacture or labeling
and filing and receiving a full BLA for this.  There are no
guidelines, much less regulations, specifying what changes in an
existing product require or allow filing for a new vs. supplemental
approval.  There are multiple recent examples of absolutely the same
product (no changes at all) receiving a new full BLA, e.g., for a new
trivial indication; and examples of products with minor changes in
their manufacturing process or formulation receiving full BLAs.  For
decades, these types of incremental changes have generally been
handled by supplemental approvals (are savvy companies already looking
ahead to gaming biosimilars regulations?).  This is further discussed
in the "What Products Deserve Exclusivity? Failure to Define New
(Different/Unique) Reference Products Provides Opportunities for
Infinite Evergreening" and other News entries at www.biosimilars.com.
Some of the issues related to difficulties in defining
biophamaceuticals and biosimilars are discussed at www.biopharmacopeia.com
.

You can't effectively regulate something unless you define it, and
pending legislation avoids defining criteria for reference (innovator)
products, the ones that will receive x years of exclusivity, other
than by BLA approvals.  In my opinion, data exclusivity provisions are
gameable, unless one can determine what changes in a reference product
(its active agent, manufacture, formulation and/or approved
indications) allow it to be eligible for data exclusivity (what
changes allow calling it a fully new or novel product), and what
changes do not count.

Why haven't biosimilar supporters been all over this?  This issue is
nothing new.  Everyone is fixated on debating years of data
exclusivity, reasons for this, and ignoring the criteria to qualify
for receiving this.  I suspect a major reason no one brings up these
issues is due to the complexity of coming up with workable criteria
(e.g., requiring revisiting "process = product" issues), with
biologics being the most complex of all commercial products.  And no
one probably wants to tell powerful politicians that their basic
assumptions are simply wrong, and that the situation is much more
fluid and complex than they presume or want to portray it.

A simple solution to this problem might be for legislation to
stipulate that FDA shall develop guidelines for what does/doesn't
deserve data exclusivity, or simply adopt the same criteria used for
orphan product marketing exclusivity (which would probably work well
enough).

And there will also be many problems with the all-or-nothing nature of
data exclusivity provisions - a reference product either receives the
full x years or nothing.  This just doesn't match up with the
realities of biologics, with a broad spectrum of newness/novelty (as
there is with biosimilarity).  There should at least be one
intermediate level (exclusivity time period), with FDA making
decisions on the length of data exclusivity.  Otherwise, this is an
issue where there will be perpetual controversies, and the laws/
regulations will likely be perceived as inherently unfair and flawed.

Thank you.

Ronald A. Rader
President / Author & Publisher of BIOPHARMA:  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:  biotech@biopharma.com
Web sites:  www.biopharma.com; www.bioinfo.com;
     www.biopharmacopeia.com; www.biosimilars.com