Synopsis
On March 13, Celltrion announced the launch of Steqeyma, a biosimilar treatment for autoimmune diseases, in the US. This marks their seventh biosimilar product in the US market, reflecting their commitment to expanding their presence in the biosimilar sector.Key Takeaways
- Celltrion has launched Steqeyma for autoimmune diseases in the US.
- The product targets multiple conditions, including psoriasis and Crohn's disease.
- FDA approved the biosimilar in December.
- Celltrion has received approval for multiple biosimilars recently.
- The company aims to commercialize 22 products globally by 2030.
Seoul, March 13 (NationPress) Celltrion, a prominent biopharmaceutical company based in South Korea, announced the launch of its biosimilar product, Steqeyma, for the treatment of autoimmune diseases in the United States on Thursday. This new treatment targets plaque psoriasis, Crohn's disease, active psoriatic arthritis, and ulcerative colitis. According to the company, this marks the seventh biosimilar product introduced to the US market.
The US Food and Drug Administration (FDA) approved the biosimilar in both intravenous and subcutaneous forms in December, as reported.
Earlier this week, Celltrion's biosimilar for asthma and other chronic allergic conditions received FDA approval for commercial distribution.
The FDA also granted approval for Celltrion's Omlyclo, a biosimilar to Xolair, which treats moderate to severe persistent asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), immunoglobulin E (IgE)-mediated food allergies, and chronic spontaneous urticaria (CSU).
This biosimilar can additionally address IgE-mediated food allergies and CSU, as mentioned by Yonhap.
Moreover, the biosimilar was awarded interchangeability status, allowing it to be substituted for the original product without the need for intervention from the prescribing healthcare provider, the company noted.
The global market for Xolair is projected to reach 6 trillion won ($4.1 billion), with 3.7 trillion won attributed to the US by 2024.
Celltrion is actively working to enhance its foothold in the US biosimilar sector.
Recently, it has secured FDA clearance for several biosimilars, including Avtozma, a treatment for autoimmune diseases similar to Actemra, along with Stoboclo and Osenvelt, which are biosimilars to Prolia and Xgeva, respectively.
The global market for Stelara is valued at approximately $10.36 billion, with the US contributing to two-thirds of the total sales.
Celltrion aspires to commercialize 22 biosimilar products in international markets by the year 2030.
