Celltrion's CT-P17 gets the nod in Canada
Celltrion's CT-P17 biosimilar was approved for sale in Canada, the company said Thursday.
The drug is an identical copy of adalimumab, better known as Humira, developed by Lake Bluff, Illinois-based AbbVie.
The nod from Canadian regulators came about ten months after the European Medicines Agency gave permission. It is being sold under the brandname Yuflyma there.
The drug was approved for sale by Korea's Ministry of Food and Drug Safety in October.
Biosimilars, according to the U.S. Food and Drug Administration (FDA), are biological products that are approved based on proof that they are highly similar to other FDA-approved products. The drugs have no clinically meaningful differences in terms of safety or effectiveness from the reference product, but they cost less.
Humira is a treatment for autoimmune diseases including rheumatoid arthritis and Crohn's disease.
Last year, Humira generated global revenues of around $19.8 billion. In Canada alone, it generated around 1 trillion won.
Among Humira biosimilars, Yuflyma is the first high-concentration formulation to receive approval from a drug administrator, Celltrion said. High-concentration means that patients can take a half a dose compared to competitors.
“Being developed as a high-concentration formulation, we are set to enter Northern America, which has the largest biopharmaceutical market in the world,” said Celltrion’s spokesperson.
BY SARAH CHEA [email@example.com]