E-DRUG: Differences in Drug Datasheets (10)
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This problem (independent labeling/product inserts for generic drugs)
is nothing compared to that likely in upcoming years as more
biosimilars, follow-on biologics, biogenerics, etc., ranging from
similar but truly innovative/novel products to exact-as-possible
copies, flood the developed countries' and international markets.
Most regulatory agencies in developed countries, e.g., U.S. and
Europe, can be expected to continue to consider every
biopharmaceutical/biologic, by its very nature, to be a distinct,
unique product (although it may be approved based on an abbreviated
filing largely involving comparisons with a prior approved product).
Each product, no matter how similar/same as another(s), will almost
certainly have its own specific labeling (perhaps, leaving it to a few
lower-end biogenerics to simply copy product inserts). This will make
it very difficult for those who, as indicated by postings in this
thread, prefer common labeling for the same generic drugs (but there
has yet been no mention yet in this thread of whether/how this
preference applies to biopharmaceuticals/biologics). Further
complicating the situation, many, if not most, biosimilars/follow-on
biologics applications will be approved based largely on similarities
involving bioequivalence testing for a single indication, but their
approvals will be largely generic in the sense that the new, similar
product will automatically receive approval for all of the indications
approved for the reference product.
Very much related to labeling is product and active agent
nomenclature, an issue discussed in articles I've authored available
at http://www.biopharmacopeia.com.
A major problem in the U.S. and probably many other countries for
those seeking uniform labeling/product inserts for generic drugs is
that applications, including labeling/inserts, are considered the
property of the applicant (although once approved, the labeling/
product inserts become non-copyright-protected public documents).
Biopharmaceuticals, particularly biosimilars and biogenerics, will
increasingly pose challenges for those who want to treat similar or
the same products as being much the same in actual practice/use (which
is often the case). Differences of opinions regarding equivalence,
interchangeability and automatic substitution will be very common, and
there will likely be many diverse and often opposing views on this,
including by pharmaceutical references, regulators, formularies,
payers/insurers, physicians and patients.
Ronald A. Rader
President / Author & Publisher - 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: ron@biopharma.com
Web sites: www.bioinfo.com; www.biopharma.com;
www.biopharmacopeia.com; www.biosimilars.com