Biopharmaceutical companies worldwide are bracing for an intense battle to take a share of the market dominated by Janssen's Stelara (ustekinumab), a monoclonal antibody recognized for its selective inhibition of cytokines L-12 or IL-23 to treat autoimmune diseases.
First approved by the U.S. Food and Drug Administration (FDA) in September 2009 and later by the Ministry of Food and Drug Safety in June 2011, Stelara has broadened its applicative scope from treating psoriasis to other autoimmune diseases, such as Crohn's disease and ulcerative colitis.
The drug accounted for 10 percent of Janssen's global sales last year after recording sales of about $9.7 billion, a 6.5 percent increase from 2021.
Stelara is also leading the pack in the Korean market. According to IQVIA, a drug market research firm, the drug was the top-selling biologic in 2022, generating 36.5 billion won ($27.2 million) in revenue.
However, with Stelara's product patent expiration in the U.S. last month, biosimilar competitors have rapidly emerged on the global stage, positioning themselves in a fierce contest for U.S. Stelara market share, totaling $6.4 billion in 2022.
Having already secured regulatory approval, some companies are accelerating their launching schedules.
Amgen's ABP 654 is poised to become the first mover among biosimilars after having solidified a deal with Janssen this May to release its biosimilar after Jan. 1, 2025.
Alvotech and Teva's AVT04 follow closely after Feb. 21, Celltrion's CT-P43 after March 7, and Fresenius Kabi and Formycon's FYB202 after April 15.
Other contenders like Samsung Bioepis and Sandoz's SB17, Dong-A Socio Holdings, Meiji Seika, Intas' DMB-3115, Bio-Thera and Hikma's BAT2206, and NeuClone's Neulara, have yet to confirm their launch schedules.
Amid the accelerating competition, Samsung Bioepis and Celltrion recently announced compelling clinical trial results at the European Academy of Dermatology and Venereology (EADV) conference in Berlin from Wednesday to Saturday.
Samsung Bioepis reported positive results from the phase 3 clinical trials of its biosimilar, SB17, conducted across eight countries, involving 503 patients with moderate to severe plaque psoriasis.
The trials, which randomized participants into SB17 and Stelara groups and swapped half of the latter group to SB17 from week 28, confirmed the bioequivalence of the biosimilar against the original drug in terms of efficacy and safety.
Celltrion's biosimilar, CT-P43, underwent a 52-week clinical trial involving 509 psoriasis patients. According to the Korean company, the efficacy and safety were comparable between the groups receiving Stelara and CT-P43, even when Stelara was substituted with CT-P43 at week 16.