The US FDA has now approved a
biosimilar version of infliximab, which is a chimeric human-mouse
monoclonal antibody. Celltrion's Inflectra
(infliximab-dyyb) can now be marketed in the US by Hospira. Janssen
Biotech, Inc. owns the blockbuster initial version of the drug,
which it has sold under the brand name Remicade since it was
approved in 1998. The Inflectra product was approved for specific
indications relating to conditions such as
Crohn's disease, ulcerative colitis, rheumatoid arthritis and
Unlike generic versions of small molecule pharmaceuticals,
follow-on versions of biologic drugs (biosimilars)
have a similar, but not identical, active ingredient as an approved
innovator drug. In particular, there can be differences in
structure, formulation, impurities or immunogenicity between the
two products which can make it difficult to compare the biosimilar
to the innovator drug. The biosimilar manufacturer must provide
substantial supporting data to regulators in comparison to
conventional follow-on small molecule pharmaceuticals. The FDA
stated that its approval of Inflectra was based on structural and
functional characterization, animal study data, human
pharmacokinetic and pharmacodynamics data, clinical immunogenicity
data and other clinical safety and effectiveness data. No
indication was given of the extent of any clinical trial data.
In 2013, the European Medicines Agency (EMA)
granted marketing authorizations to two biosimilar
Celltrion/Hospira versions of infliximab (brand names Remsima
and Inflectra). The EMA found that both Remsima and Inflectra had a
comparable quality, safety and efficacy profile to
Remicade. In 2014, Canada also approved the drugs for
marketing authorization based on biosimilarity, following the
This is the second biosimilar authorized by the FDA. The EMA has
authorized more than a dozen biosimilar medicines to date including
biosimilar versions of somatropin (recombinant human growth
hormone), filgrastim (granulocyte colony-stimulating factor analog)
and epoetin alfa (synthetic erythropoietin).
In the bigger picture, this FDA approval should provide further
insight on the FDA's criteria for approving biosimilars of
complex biologics. The monoclonal antibody approval is significant
from a regulatory perspective because antibodies present additional
comparability challenges compared to early commercial biologics
which have lesser size and complexity. For example, monoclonal
antibodies can be 10 to 15 times larger than the early biosimilars
like human growth hormone and erythropoietin. There is a widespread
interest in industry for additional guidance to those planning to
market their own biosimilar antibodies. It has been estimated that
there were at least 49 biosimilar mAbs under
development as of September, 2011.
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