On 5 November 2026, Celltrion announced that it launched three biosimilars in Brazil in October 2026: Qoyvolma®, biosimilar to Janssen’s Stelara® (ustekinumab), and Stoboclo® and Osenvelt®, biosimilars to Amgen’s Prolia® and Xgeva® (denosumab), respectively.
Qoyvolma® is approved for the treatment of plaque psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis. Stoboclo® and Osenvelt® are approved for the same indications as the reference medicine.
With this launch, Celltrion’s product range in Brazil has expanded to a total of 10 products, including infliximab, adalimumab, and omalizumab biosimilars. Celltrion is planning to launch Eydenzelt®, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept) and Avtozma®, biosimilar to Roche’s Actemra® (tocilizumab), in Brazil before the end of the year.
The launch of Celltrion’s ustekinumab biosimilar follows news that Biocon’s Yesintek® (ustekinumab) was permitted to enter the Brazilian market “with immediate effect” following a settlement agreement entered into by Biocon and Janssen in October 2026. Bio-Thera and Biomm entered a licensing agreement for Bio-Thera’s BAT2206 (ustekinumab) in Brazil in June 2023.
There have been at least two reported denosumab biosimilar approvals in Brazil to date. Sandoz’s Denbonli® (referencing Amgen’s Prolia®) and Wyost® (referencing Amgen’s Xgeva®) received approval in September 2025. Abbott/mAbxience received approval for two unnamed denosumab biosimilars in June 2026. There are denosumab biosimilars under development for the Brazilian market by at least Mabwell/Cristália (strategic agreement entered August 2024) and Boan Biotech and an unnamed strategic partner (strategic agreement entered November 2024).
