[Ip-health] New Bill in Congress calls for 14 years of Data Exclusivity

[Biotech.Info.Inst.]

--
[ Picked text/plain from multipart/alternative ]
The draft bill, "Pathway for Biosimilars Act," introduced by Rep.
Eshoo has been published.  See http://www.biosimilars.com/draft_eshoo_bill.pdf
.  The term biosimilars is now being used.  This bill includes
exclusivity provisions for both innovator and biosimilar versions,
while giving FDA broad authority to regulate products one-at-a-time,
including determining needed clinical trials.  It requires FDA to
issue product class guidance before approving a product, and requires
use of a fully unique (not generic) name for the product (unstated
what this will be, e.g., a name indicative of generic relationships or
the U.S. trademark, and who selects it).

Strangely, the bill requires biosimilar sponsors to provide the
sponsor of the reference product with a copy of its full BLA and
detailed information about their product's manufacture.  Thus,
biosimilar sponsors must provide all of their proprietary information
to their prime competitor, with no provision for any public disclosure
of information (no transparency or public oversight).  The reference
product sponsor must then provide the biosimilar sponsor with a list
of any patents it intends to assert against the biosimilar (again,
with no public disclosure).

One problem is that the bill uses full/original BLAs as the sole
criteria to determine eligibility for exclusivity.  But, considering
only original full BLA approvals as the criteria for defining a
reference product is unwieldy and easily gamed!  From my experience,
there is and has been no logic or consistency to CBER biologics
approvals, i.e., what differences or changes in a product result in a
full/original vs. a supplemental approval.  Relatively trivial changes
can result in a full/original BLA, e.g., if the applicant simply has
filed a full BLA (which for the same sponsor can be substantially
abbreviated, including trials) rather than a supplemental BLA, as is
usually granted for incremental changes.  And major changes, including
in the identity/nature/manufacture of the product and new indications,
that would generally be considered as defining new/different products
can and have received supplemental approvals.

A recent example of this situation is the full BLA granted to Xyntha,
recombinant Factor VIII from Wyeth, a reformulation of and replacement
for ReFacto.  Would this new product, with the same active agent,
minimal clinical trials (no large Phase III-type trials), with its
manufacture now updated to not include any animal or human products.
Should this be considered new and given 12 years of exclusivity (as
the Eshoo bill would, based on it receiving a full BLA); should this
product be included in the 12 years exclusivity granted to ReFacto
based on ReFracto's original approval (in 2000), as some might say it
should based on the active agent and use being the same; should two
years additional exclusivity be added to ReFracto's 12 years
exclusivity, based on Xyntha being an upgrading of ReFracto; or does
this deserve no additional exclusivity?

Another example of the pitfalls of relying solely on BLA approvals to
determine what is/isn't new and different products:  Amgen
manufactures bulk recombinant erythropoietin (EPO) for use in Epogen,
which it markets in the U.S. for kidney/dialysis-related indications.
Ortho/J&J receives this same bulk EPO, formulates it as Procrit (the
same formulation as Epogen), and markets Procrit the U.S. for cancer-
related indications.  There is only one original approval (and related
supplemental approvals), granted to Amgen, with the two branded
products marketed by both companies considered by FDA to be the same,
with both Procrit and Epogen technically approved for both kidney/
dialysis- and cancer-related indications.  Both Epogen and Procrit are
marketed independently by Amgen and Ortho/J&J in the U.S., with each
having well over $1 billion in annual sales in the U.S. alone.  Should
Epogen and Procrit be considered the same or different products?  They
are the same from an entity (active agent/product and manufacturing)
perspective, the same from a simplistic regulatory perspective, but
are fully unique, distinct products from a market(ing) perspective.
Or, are they different (from both an entity and marketing
perspective), because two different companies process/formulate the
final product and market it independently?  Do you go by FDA and
consider these both to be the same product?  This would mean approval
of a biosimilar tested and approved for only one of the indications
for which Epogen/Procrit are approved for would receive approval for
all of Epogen's/Procrit's approved indications.  Or should one include
real-world, e.g., marketing, considerations in defining what is/isn't
a unique product in determining biosimilarity and exclusivity?

Defining what is a distinct biopharmaceutical (a requisite starting or
reference point for biosimilars), much like determining biosimilarity,
is a difficult and currently very subjective task.  See my two-part
series, ""What Is a Generic Biopharmaceutical? Biogeneric? Follow-On
Protein? Biosimilar? Follow-On Biologic?," published in BioProcess
International (available at http://www.biosimilars.com and http://www.biopharmacopeia.com
).

Otherwise, can anyone provide or refer me to any studies, articles,
backgrounders, etc. that present BIO's, PhRMA's, GPhA's and anyone's
views of the rationale and need for 12-14 years of exclusivity for
innovator/novel biologics?   I follow this issue closely, but have
never seen any related documentation.  Where did this come from?  How
was this number arrived upon, vs. say the 7 years granted to orphan
products or no exclusivity?  Is 12-14 years exclusivity based on
failure of the patent system to protect novel products; compensating
for lengthy product development periods and delays on the part of FDA;
or what?

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.biopharmacopeia.com; www.followonproteins.com