Celltrion Pharm announced on the 2nd that it will begin domestic sales of ‘Avtozma’ (a biosimilar of ACTEMRA, ingredient name tocilizumab), a treatment for autoimmune diseases.
ACTEMRA, developed by Swiss Roche, is an interleukin inhibitor that reduces inflammation by inhibiting interleukin (IL)-6 protein involved in causing inflammation. Rheumatoid arthritis (RA), systemic juvenile idiopathic arthritis (sJIA), and polyarticular juvenile idiopathic arthritis (pJIA) are the main diseases treated. Last year, global sales reached approximately 2.645 billion Swiss francs (4 trillion won). The domestic market size is estimated at about 20 billion won.
According to global phase 3 clinical trials of Avtozma conducted by the developer Celltrion involving a total of 471 rheumatoid arthritis patients, Avtozma met the equivalence criteria compared to the original drug and confirmed its efficacy, equivalence, pharmacokinetics, and safety.
Based on this, Celltrion obtained product approval for Avtozma in the U.S. and Europe consecutively in January and February, and also received approval in December of last year for ‘Avtozma intravenous’ as the first biosimilar of tocilizumab in Korea.
In February, it obtained product approval for the subcutaneous injection (SC) formulation ‘Avtozma Subcutaneous Injection (162 mg)’, which will be launched this month with a listed price of 245,938 won.
The recently launched Avtozma Subcutaneous Injection (auto-injector type) has improved administration convenience and safety compared to existing products. While the existing competitor products require pressing an external injection button to administer the drug, the Avtozma Subcutaneous Injection allows for immediate drug delivery by pressing the syringe against the skin. It has resolved the issue of drug loss caused by incorrect injection angles during administration. After undergoing separate stability tests, the expiration date has been extended to 36 months from the manufacturing date—a 12-month increase compared to the 24-month period of competing products.
To secure a competitive edge with the launch of this SC formulation, Celltrion Pharm plans to hold information sessions for medical personnel. It also plans to release the intravenous (IV) formulations of Avtozma (80 mg, 200 mg, 400 mg) within the year.
Including this product, the biosimilar product lineup that Celltrion Pharm is selling in Korea has increased from 6 (Remsima, Remsima SC, Truxima, Herzuma, Uplyma, Vegzelma) announced during the Vision 2030 declaration in August of last year to a total of 12 (Stovolco, Osentbelt, Idenselt, Steqeyma, Omliclo, Avtozma).
A representative from Celltrion Pharm noted, “Avtozma will quickly penetrate the domestic market based on its enhanced convenience and first-mover advantages, and we expect significant growth in the biosimilar institutional sector with a major expansion of our product portfolio this year.”