Celltrion said on the 22nd that it obtained approval from Japan's Ministry of Health, Labour and Welfare for its autoimmune disease treatment "AVTOZMA."
AVTOZMA is a biosimilar (biologic copy) of the original drug "Actemra (Actemra, generic name tocilizumab)" owned by Swiss pharmaceutical corporations Roche (Roche).
It is an interleukin (IL) inhibitor that reduces inflammation by blocking the action of interleukin (IL)-6, which is involved in triggering inflammation in the body, and Actemra recorded global sales of about 2.645 billion francs (Hanwha about 4 trillion won) last year.
AVTOZMA secured approvals for the main indications (target disease groups) held by the original drug, including rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA), Castleman disease (CD), and cytokine release syndrome (CRS).
Celltrion plans to expedite the launch of AVTOZMA in Japan as a first-mover biosimilar and move quickly to expand its market share. According to the pharmaceutical market research firm IQVIA (IQVIA), the Japanese tocilizumab market was estimated at about $316 million (Hanwha about 440 billion won) as of last year.
A Celltrion official said, "It is particularly meaningful that AVTOZMA became the first tocilizumab biosimilar to obtain approval in Japan, one of the world's key pharmaceutical markets," adding, "We will do our best to provide patients with a stable, economical treatment option and to expand our presence in Japan's autoimmune disease treatment market."