This file photo provided by Celltrion shows its biosimilar medicine Yuflyma. (Yonhap)
SEOUL, April 14 (Korea Bizwire) — Celltrion Inc., a major South Korean biopharmaceutical firm, said Monday it has obtained an interchangeability approval for its biosimilar drug for autoimmune disease treatment in the United States.
The U.S. Food and Drug Administration (FDA) designated Celltrion’s biosimilar Yuflyma as interchangeable medicine for its original drug Humira in the U.S., the company said in a press release.
Interchangeability approval is a designation given to drugs that can be substituted for another drug at pharmacies without doctors’ prescriptions.
The global Humira market reached 12.59 trillion won (US$8.99 billion) last year, with nearly 80 percent of the sales in the U.S. market, it said.
Celltrion expects the interchangeability approval will help drive up its Yuflyma sales in the world’s biggest pharmaceutical market.
Celltrion has significantly expanded its global biosimilar lineup, increasing the number of approved products from six to 11.
It aims to commercialize 22 biosimilar products by 2030, when the targeted global market size is expected to nearly double to 261 trillion won from 138 trillion won this year.
(Yonhap)
