Celltrion wins EU approval for autoimmune disease treatment Avtozma

Celltrion Inc.’s Avtozma, a biosimilar to Roche’s autoimmune disease treatment Actemra, has won approval from the European Commission, following approvals in South Korea in December and in the US last month.

Avtozma is an interleukin inhibitor that reduces inflammation by suppressing the interleukin (IL)-6 protein, which triggers inflammation in the body.

With this approval, Celltrion expands its autoimmune treatment portfolio beyond tumor necrosis factor-alpha (TNF-α) inhibitors to include interleukin inhibitors.

Earlier this month, the South Korean biosimilar maker secured approval for three other drugs from Europe: Eydenzelt, referencing blockbuster eye disease treatment Eylea; Stoboclo and Osenvelt. Stoboclo and Osenvelt are biosimilars to Prolia and Xgeva.

These additions bring the company’s European portfolio to 11 biosimilars.

The global market for the original drug Actemra is estimated at 4 trillion won ($3 billion) annually, with that of Eylea worth about 13 trillion won.

The market for Prolia and Xgeva, used for osteoporosis and bone metastasis complications, is estimated at a combined 9 trillion won worldwide.

Celltrion’s product lineup of approved or marketed biosimilars spans autoimmune treatments such as Remsima; Remsima SC, a subcutaneous injection type sold under the brand name of Zympentra in the US; Yuflyma; and Steqeyma, as well as oncology drugs including Herzuma, Truxima and Vegzelma.

The combined market value of their original drugs is estimated at 150 trillion won ($112 billion).

Write to Dae-Kyu Ahn at powerzanic@hankyung.com
 


Yeonhee Kim edited this article.