Celltrion's 'Uplima', Additional Approval for High-Dose Formulation Sales in Europe

Celltrion biosimilar (biopharmaceutical generic) 'Yuflyma' 40mg/0.4ml

[Asia Economy Reporter Chunhee Lee] Celltrion's Humira (active ingredient 'adalimumab') biosimilar, Uplyma (CT-P17), aims to expand its market by supplying various dosages across Europe.

Celltrion announced on the 22nd that it recently received marketing authorization for the 80mg/0.8ml dosage form of Uplyma. This came about two months after receiving a positive opinion for additional marketing approval from the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) in December last year. With this, Uplyma can now be supplied in two dosage forms in Europe: the existing 40mg/0.4ml and the new 80mg.

Uplyma is the world's first high-concentration formulation Humira biosimilar, approved by the EMA and launched in February last year. It has started sales in the European market for all indications covered by Humira, including rheumatoid arthritis (RA), inflammatory bowel disease (IBD), and psoriasis (PS). It also received approval from the Ministry of Food and Drug Safety in Korea in October last year and is preparing for domestic market launch.

With the additional approval of Uplyma's dosage form in Europe, Celltrion expects market expansion by enabling broader prescriptions according to patient and healthcare provider demand. Patients requiring higher doses can now be prescribed the 80mg formulation of Uplyma from the start, increasing the likelihood that they will choose Uplyma for subsequent treatments.

Humira, sold by AbbVie in the United States, is a blockbuster biopharmaceutical and ranks first in single-product sales globally. It recorded sales of $20.7 billion (approximately 24.7365 trillion KRW) last year. Notably, since AbbVie obtained approval for Humira's high-concentration formulation in Europe, more than 90% of Humira sold in Europe is known to be the high-concentration formulation.

A Celltrion official stated, "By diversifying the product line of Uplyma, the world's first high-concentration biosimilar approved in Europe, we have laid the foundation to further enhance patient convenience. We will continue to do our best to ensure that more patients can benefit from high-quality biopharmaceuticals."

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