Celltrion's Humira biosimilar gets FDA nod

Celltrion's adalimumab biosimilar CT-P17 has been approved the US Food and Drug Administration, the company announced Wednesday.

CT-P17, also known as Yuflyma, is the world’s first high-concentration, low-volume and citrate-free biosimilar of Humira, an injectable treatment for rheumatoid arthritis and other autoimmune conditions.

Celltrion said CT-P17 had been approved as a treatment for multiple chronic inflammatory diseases, including rheumatoid arthritis, inflammatory bowel disease, psoriasis and juvenile idiopathic arthritis.

Sales of CT-P17 in the US will begin in July and compete with other Humira biosimilars to increase its share in the US market, which makes up a significant proportion of the world’s Humira market.

Since its launch in 2003, Humira has reportedly created around $200 billion in revenue for two decades, becoming the world’s top selling drug since 2012. Last year, AbbVie made $21.2 billion of sales through Humira. Humira’s sales in the US market accounted for some 87 percent of the total annual sales last year.

Celltrion’s CT-P17 is expected to compete with at least seven Humira biosimilar products developed by Amgen, Pfizer, Boehringer Ingelheim, Organon and Samsung Bioepis, Biocon, Coherus Biosciences and Sandoz.

Celltrion expected CT-P17’s successful debut in the US adalimumab market, which is shifting to higher concentrations that can offer patients reduced injection volume. High-concentration formulations accounted for approximately 85 percent of adalimumab sold in the US last year, Celltrion said, quoting reports from Symphony Health and IQVIA.

Meanwhile, Celltrion is also conducting a global phase 3 clinical study to establish interchangeability between CT-P17 and Humira in both Europe and the US.

With an interchangeability designation, a biosimilar can be substituted for its reference product at the pharmacy, without additional approvals from the prescribing physician.