Last year, the European Medicines Agency (EMA) granted marketing
authorizations to two biosimilar versions of Johnson &
Johnson's rheumatoid arthritis blockbuster drug
Remicade1. The active substance of Remicade is
infliximab, a chimeric humane-mouse monoclonal antibody (mAb).
Remicade has been authorized in the European Union since August
1999. The EMA's acknowledgment that Celltrion's Remsima and
Hospira's Inflectra can be compared to Remicade is the first
time that mAbs were deemed to be biosimilar in the EU. In the
bigger picture, this provides further insight on the EMA's
criteria for approving biosimilars of complex
biologics. Canada has now approved the drugs for marketing
authorization based on biosimilarity, following the EMEA's
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
The EMA has authorized at least 12 biosimilar medicines to date
including biosimilar versions of somatropin (recombinant human
growth hormone), filgrastim (granulocyte colony-stimulating factor
analog) and epoetin alfa (synthetic erythropoietin). However, mAbs
present additional comparability challenges compared to these early
commercial biologics given their size and complexity. For example,
mAbs can be 10 to 15 times larger than human growth hormone and
In May of 2012, the EMA released guidance setting out an
approval pathway for mAbs (Guideline on similar biological
medicinal products containing monoclonal antibodies –
non-clinical and clinical issues)2. The EMA issued
its opinions on Remsima and Inflectra by reference to this
Guideline. This Guideline, like all the EMA biosimilars guidelines,
emphasizes the demonstration of comparability to the reference
drug. The EMA found that both Remsima and Inflectra had a
comparable quality, safety and efficacy profile to Remicade.
The recommendation by the EMA to approve Remsima and Inflectra
provides additional guidance to those planning to market their own
biosimilar antibodies. Indeed, it has been estimated that there
were at least 49 biosimilar mAbs under development as of September,
20113. It will also be interesting to see how other
jurisdictions such as the United States, which introduced a
specialized, abbreviated approval pathway for biosimilars in March
of 20104 but has yet to approve a mAb biosimilar, will
treat follow-on antibodies.
Effective September 1, 2016, the Disposition of Surplus Real Property Regulation to the Ontario Education Act was amended with the intention to reduce barriers to the formation of health and community hubs in Ontario.
Health Canada is proposing to change the way that it regulates non-prescription drugs, natural health products and cosmetics in Canada, which will now be referred to collectively as "self-care products."
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