Celltrion applies for EMA approval of smaller dose formulation of Yuflyma
Jae-Young Han
Jan 16, 2023 (Gmt+09:00)
Celltrion's Yuflyma Celltrion Inc. announced on Monday it applied to the European Medicines Agency (EMA) for approval of a 20 mg/0.2 mL formulation of Yuflyma, a biosimilar of Humira (active ingredient: adalimumab), an autoimmune disease treatment developed by AbbVie of the US.
Currently, the South Korean biosimilar giant holds licenses for dosage formulations of 40 mg/0.4 mL and 80 mg/0.8 mL of Yuflyma.
If the 20 mg/0.2 mL formulation is allowed, it will enable Celltrion to serve a wider range of pediatric patients including those who weigh less and require low-dose administration.
"If the 20 mg dosage formulation is approved in Europe, medical staff and patients will have more options to choose prescriptions according to various needs," a Celltrion official said.
Celltrion expects the diversified Yuflyma lineup to help it satisfy the required conditions for bidding participation in some countries or to receive higher scores in evaluations.
Yuflyma's original drug, Humira, is a blockbuster biopharmaceutical with global sales of $31.6 billion in 2021, ranking first in single-item sales in the global market.