Celltrion said on Wednesday it is aiming to distribute Yuflyma, a Humira biosimilar, in the United States from July next year as it has completed a patent agreement with AbbVie, the U.S. market exclusivity owner of the original adalimumab medicine.

The Korean drugmaker submitted an NDA to the U.S. Food and Drug Administration (FDA) in November 2020 in hopes to get approval of Yuflyma this year. Yuflyma, a high-concentration formulation of adalimumab, is expected to be more convenient for patients with reduced single injection volume. It is also citrate-free, meaning it causes less pain after administration.

In Europe, Yuflyma was approved in February last year for all indications held by its reference drug to treat autoimmune diseases such as rheumatoid arthritis, inflammatory bowel disease, and psoriasis. Celltrion Healthcare responsible for overseas distribution of Yuflyma 40㎎ started marketing last year and received additional approval for a 80㎎ formulation in February this year.

Celltrion Pharm, the domestic distributor of Yuflyma, began domestic sales last month after marketing clearance in October last year. The drug was also approved in Canada last December.

The original Humira generated $20.7 billion in global sales last year, $17.3 billion of which came from the U.S. market.

By Han Jae-beom and Minu Kim

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