Celltrion to sell Yuflyma in U.S. from July next year

Celltrion's Yuflyma [CELLTRION]

Celltrion said Wednesday it has reached an agreement with AbbVie that allows it to sell its biosimilar product of Humira in the U.S. market starting July next year.

Celltrion’s biosimilar product, Yuflyma, is an identical copy of adalimumab, better known as Humira, developed by Lake Bluff, Illinois-based AbbVie. It is currently waiting for approval from the U.S. Food and Drug Administration (FDA) which the company predicts will come within the year.

AbbVie’s patent for Humira will expire in January 2023. But biopharmaceutical companies often hold patents for related technology that prevents other companies from launching biosimilar products after the patents expire. The latest agreement with AbbVie removes all hurdles Celltrion would face to enter the U.S. market, the company said, though specific details about the deal have not been disclosed.

Biosimilars, according to the 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 used to treat autoimmune diseases including rheumatoid arthritis and Crohn's disease. It generated global revenue of $20.7 billion last year, $17.3 billion of which came from the U.S. market.

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 half a dose compared to products from competitors.

Yuflyma has so far received use authorizations from Korea, European Medicines Agency and Canada.

“With the latest patent agreement [with AbbVie], we got to release Yuflyma in the U.S. market safely,” said a spokesperson for Celltrion. “The agreement is meaningful in that we could show the competitiveness of our high-concentration product to U.S. patients early.”

BY SARAH CHEA [chea.sarah@joongang.co.kr]