[Ip-health] Seeking Comments/Info. Regarding WHO Assigning Unique INNs to All Biopharmaceuticals

[Ron Rader]

On Nov. 21, I posted a message alerting the list that nomenclature,
particularly the official names to be assigned and used for
biogenerics/biosimilars, will become a contentious public issue.  I
received no responses.

In the past week, the major European and U.S. pharmaceutical and
biotechnology trade associations (including EFPMA, EFPIA, EUROPABIO,
EBE, PhRMA and BIO) banded together to support, each put out a press
release and most issued position papers concerning a proposal that
WHO adopt a policy of granting unique International Nonproprietary
Names (INNs) to each biopharmaceutical product from each company.
Thus, for biopharmaceuticals, INNs would no longer be generic names
based on the active agent.  The rationale cited by industry for this
change is safety - (simplistically stated) many countries have
deficient regulatory systems (including the EU and many lesser-
developed countries) that do not assign or otherwise assign unique
official names/identifiers for each pharmaceutical upon approval  (as
in the U.S.) and allow prescriptions and generic substitution based
on INN generic names.  Innovator industry portrays this as unsafe for
biogenerics/biosimilars (that have not been ruled as therapeutically
substitutable, which many in industry still assert is an
impossibility).  I believe this is a pressing concern for EU-
operating companies, since the EU has not adopted official names (or
a related policy) for biosimilars, of which several (somatropins) are
now entering the market.

Have any non-industry-backed organizations yet taken a stand on the
WHO proposal and the broader issues of how to name generic
biopharmaceuticals (whether to use unique or generic names, and who
should devise and assign these)?  I am finishing up multiple articles
for submission to trade periodicals (Genetic Eng. News, Nature
Biotechnology, and BioProcess Intl.) on these issues.  I particularly
welcome information and comments (on and off the list) from those
opposed to altering the nomenclature system (vs. perhaps having WHO
recommend each country that relies upon names for prescriptions and
generic substitution adopt their own official names for
biopharmaceuticals reflecting their own evaluations of similarity and
generic substitutability).

Or, is this simply a non-issue?  Will WHO ignore the united front and
arguments from industry?  [But this still leaves the issue of names
unresolved in many countries, including in the U.S. in the context of
proposed generics biologics legislation].

Thank you.

Ronald A. Rader
President
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.biopharmacopeia.com;
     www.followonproteins.com; www.bioinfo.com