Celltrion Completes Patent Agreement with AbbVie... 'Uplyma' to Be Sold in the US Starting July Next Year

No Obstacles to US Sales, Fast Market Entry Possible
FDA Approval Expected Within the Year... "Focusing on Entering the US Humira Market"

Celltrion's Humira Biosimilar 'Yuflyma'

[Asia Economy Reporter Lee Gwan-ju] Celltrion announced on the 27th that it has finalized a patent agreement in the United States with AbbVie, the developer of the autoimmune disease treatment 'Humira (active ingredient adalimumab).' As a result, Celltrion can begin selling the Humira biosimilar 'Yuflyma' in the U.S. starting July 2023.

Celltrion completed the approval application for Yuflyma with the U.S. Food and Drug Administration (FDA) in November 2020 and expects approval within the year. Following this patent agreement, Celltrion will enter the U.S. Humira biosimilar market from July next year, leveraging the differentiated product features of a high-concentration formulation.

Yuflyma, developed by Celltrion, is the world's first high-concentration Humira biosimilar approved by the European Medicines Agency (EMA). Compared to the low-concentration version, it reduces the drug dosage by half and is formulated without citrate, which can cause pain.

In February last year, Celltrion obtained EMA approval for Yuflyma for all indications covered by Humira, including rheumatoid arthritis (RA), inflammatory bowel disease (IBD), and psoriasis (PS). Sales in the European market began through Celltrion Healthcare, which handles overseas sales of Yuflyma. Additionally, in February this year, after receiving approval for an 80 mg/0.8 ml dosage form following the initial 40 mg/0.4 ml dosage, broader prescriptions became possible in Europe.

In October last year, Celltrion obtained sales approval for Yuflyma from the Korea Ministry of Food and Drug Safety and officially started domestic sales last month. In December last year, it also received sales approval from Health Canada and recently began sales in Canada, marking a full-scale entry into the North American market.

The original drug Humira, from which Yuflyma is derived, is a blockbuster biopharmaceutical sold by AbbVie in the U.S., recording sales of approximately $20.7 billion (about 25.3368 trillion KRW) last year. Of this, the U.S. market accounted for $17.33 billion (about 21.2119 trillion KRW). A Celltrion official stated, "With this patent agreement, we can stably launch Yuflyma in the U.S., the largest market for adalimumab. Entering the U.S. market early allows us to showcase the differentiated competitiveness of the high-concentration Humira biosimilar to autoimmune disease patients in the U.S., making this agreement significant."

This content was produced with the assistance of AI translation services.