Celltrion has completed a permit application to Health Canada for Remsima SC, the world's first infliximab hypodermic autoimmune disease drug, on Feb. 13 (local time).
In order to gain strong competitiveness in the TNF-α inhibitor (self-immune disease treatment) market, Remsima SC was a self-developed antibody biologic drug that was approved for sale by the European Medicines Agency (EMA) in November last year.
Canada's health agency will conduct a licensing review for about a year in the form of
"Biobetter" in recognition of the vast clinical data that Celltrion submitted to the European Medicines Agency (EMA).
Meanwhile, the Food and Drugs Administration (FDA) in the U.S. judged Remsima SC as a "new drug" and, in close consultation with the FDA, Celltrion was exempted from first and second-phase clinical trials and began to receive a three-phase clinical trial in July last year.
Canada is pushing for a "duty-switching policy" to expand the use of biosimilars at the state level to cut down on health care costs, and to allow the use of original medicines only in exceptional cases.
The first to introduce such a strong biosimilar policy is British Columbia, followed by Ontario and Alberta, which are also considering biosimilar switching policy, which is expected to further spread in Canada this year.