Jan 8 Johnson & Johnson on Wednesday
said it submitted a citizen petition asking that U.S. health
regulators require copies of biological products to bear names
that are similar and not identical to those of their reference
J&J's view on naming of biosimilars contrasts that of Mylan
Inc and Novartis AG over the past few months,
as the U.S. Food and Drug Administration continues to work on
drafting regulations for the approval of biosimilars -- cheaper
versions of expensive biologics, or the original reference
"Assigning names that are similar but not the same will
appropriately reflect the legal and scientific reality that
biosimilars are similar to but not the same as their reference
products or other biosimilars," J&J's Chief Biotechnology
Officer Jay Siegel said in a statement.
Creating copies of biologics is complicated as these
products are produced in living cells, bringing inevitable
unpredictability. As a result, their copies can only ever be
"similar," not exact replicas.
Names of biosimilars are also bound to impact their sales
and adoption as substitutes to the original products.
Novartis and Mylan have both previously expressed support
for a system that requires that a biosimilar share the same
international non-proprietary name (INN) as the biologic
products to which it refers, saying that same names would avoid
frivolous brand tactics and confusion in the marketplace.
Mylan in September said it supported a petition filed by the
Washington, DC-based Generic Pharmaceutical Association that
recommended biosimilars have the same names because by
definition they are highly similar to their reference products
and have no meaningful differences that require a unique
Novartis advocated for the same by filing its own petition
Biologic medicines, typically administered via an injection,
and are used to treat cancers, immunological diseases like
rheumatoid arthritis and multiple sclerosis and other chronic
illnesses, but their high price tag can keep them out of reach
for many patients.
The FDA in February 2012 issued draft guidance on approval
pathways for biosimilars, but is yet to finalize that guidance,
while European regulators have already cleared cheaper copies of
some biotech medicines.
The global biosimilars market is expected to be worth about
$11 billion to $25 billion in 2020, equivalent to a modest 4 to
10 percent of total biotech drug sales by that time, according
to healthcare information firm IMS Health.