Celltrion said that Health Canada, which authorizes medicinal products, has granted sales approval to Yuflyma, a new biosimilar of Abbvie's blockbuster drug, Humira (Ingredient: Adalimumab).

Celltrion has received a nod to market Yuflyma, a biosimilar drug of AbbVie's Humira that treats autoimmune diseases, in Canada.
Celltrion has received a nod to market Yuflyma, a biosimilar drug of AbbVie's Humira that treats autoimmune diseases, in Canada.

The company has gained approval for Humira's indications, including rheumatoid arthritis, inflammatory bowel disease, and psoriasis.

"Yuflyma received marketing approval from Canada following Europe and Korea, accelerating its entry into North America, the world's largest biopharmaceutical market," a company official said. "We will do our best to provide Yuflyma to Canadian autoimmune disease patients promptly."

According to Celltrion, Yuflyma is the world's first high-concentration formulation of the adalimumab-based biosimilar. While the existing Humira biosimilar products used a low concentration, the company’s biosimilar uses a high concentration formulation that reduced the dosage of drugs in half and removed citrate, which can cause pain in patients, it said.

Yuflyma's original drug, Humira, is an autoimmune disease treatment developed by Abbvie. The drug is the most sold blockbuster drug globally and has recorded about 22 trillion won ($19.9 billion) in global sales last year. In addition, Humira was the second-best-selling biopharmaceutical in Canada last year, with sales of about 1 trillion won in the Canadian market alone.

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