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Celltrion’s Humira biosimilar gains European sales approval

South Korea’s newest Humira biosimilar is high-concentrate and citrate-free, just like the updated original

Celltrion’s Yuflyma, an adalimumab biosimilar for autoimmune diseases, has been given the green light by the European Commission on Feb. 11, allowing for it to be sold in the European market, Celltrion announced Monday.

Yuflyma is the world’s first Humira biosimilar that is high-concentrate and citrate-free, just the way the original drug was updated and where the rest of the market is headed, Celltrion said. The removal of citrate reduces the pain experienced by patients immediately after injection, according to Celltrion.

Celltrion is poised to gain a chunk in the market previously dominated by Humira, with its comparatively affordable biosimilar alternative.

Humira, developed by US’ Abbvie, reportedly notched 22 trillion won ($20 billion) in revenue last year, making it the blockbuster biopharmaceutical with the No. 1 revenue globally.

Ever since Abbvie acquired the permit to sell the high-concentrate update of Humira in Europe in 2015, more than 90 percent of the Humira used in Europe was tallied to be the new type, Celltrion said.

Yuflyma was approved for all 12 autoimmune indications of Humira’s, which are: rheumatoid arthritis, juvenile idiopathic arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, paediatric plaque psoriasis, hidradenitis suppurativa, Crohn’s Disease, paediatric Crohn’s disease, ulcerative colitis, uveitis and paediatric uveitis.

Celltrion Healthcare will oversee the marketing and distribution of Yuflyma in Europe.

The Yuflyma 40 milligram solution for injection comes in pre-filled syringes and pre-filled pens to facilitate administration for doctors.

Celltrion is developing a number of biosimilars to challenge the market dominated by original blockbuster biopharmaceuticals.

So far it has Remsima (infliximab), Truxima (rituximab), Herzuma (trastuzumab) and Remsima SC in the global market for autoimmune diseases and breast cancer.

The company has a list of five other biosimilar pipelines ready to culminate final phase of clinical trials every year from 2021 to 2024. The biosimilars copy colorectal cancer treatment Avastin by Roche, macular degeneration treatment Eylea by Regeneron, chronic spontaneous urticaria treatment Xolair by Genentech and Novartis, psoriasis treatment Stelara by Janssen and osteoporosis treatment Prolia by Amgen.

By Lim Jeong-yeo (kaylalim@heraldcorp.com)
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