Celltrion said that it recently completed a patent agreement with AbbVie, the developer of the blockbuster autoimmune disease treatment Humira (Ingredient: adalimumab), and will start selling its biosimilar version, Yuflyma, in the U.S. from July 2023.

Celltrion has reached a patent agreement for its Humira biosimilar, Yuflyma, with AbbVie, the original developer, allowing them to market its biosimilar in the U.S. from July 2023.
Celltrion has reached a patent agreement for its Humira biosimilar, Yuflyma, with AbbVie, the original developer, allowing them to market its biosimilar in the U.S. from July 2023.

Celltrion applied Yuflyma to the U.S. Food and Drug Administration in November 2020 and expects approval this year.

With the patent agreement, the company plans to enter the U.S. Humira biosimilar market based on the differentiated marketability of high-concentration formulations from next year.

“According to this patent agreement, we can stably launch Yuflyma in the U.S., the largest market for adalimumab,” a company official aid. “By entering the U.S. market early, we expect to show the differentiated competitiveness of the high-concentration Humira biosimilar to patients with autoimmune diseases in the U.S.”

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 product uses a high-concentration formulation that reduces the dosage of drugs in half and removes citrate that can cause pain in patients.

The company has received approval for biosimilar in the EU, Korea, and Canada.

Yuflyma's original drug, Humira, is the most sold blockbuster drug globally and has recorded about 25 trillion won ($20.7 billion) in global sales last year. The drug recorded sales of 21 trillion won in the U.S. market alone.

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