On 24 July 2024, Bio-Thera Solutions announced that the FDA BLA and EMA MAA for its BAT2206 have both been accepted. BAT2206 is the first biosimilar to Janssen’s Stelara® (ustekinumab) developed by a Chinese company to be submitted to the FDA or EMA for approval.
Bio-Thera is behind the race on this molecule, following three earlier EU approvals with Alvotech/Stada’s Uzpruvo® approved in January 2024, Samsung Bioepis’ Pyzchiva® in April 2024, and Amgen’s WezenlaTM in June 2024. On 1 July 2024, CHMP also recommended marketing authorisation for Celltrion’s Steqeyma (CT-P47, ustekinumab).
In the US, the FDA has previously approved Samsung Bioepis’ Pyzchiva® (1 July 2024), Alvotech/Teva’s SelarsdiTM (April 2024) and Amgen’s Wezlana® (October 2023). More approvals and launches are anticipated in the US in light of J&J/Janssen’s ustekinumab settlements with Accord BioPharma (BLA accepted January 2024, US launch date no later than 15 May 2025), Celltrion (application submitted with FDA in June 2023, US launch date of 7 March 2025) and Fresenius Kabi and Formycon (US launch date no later than 15 April 2025).
In November 2023, Bio-Thera announced that its Phase III study of BAT2206 demonstrated it is highly similar to Stelara® in patients with moderate to severe plaque psoriasis.
Bio-Thera’s BLA for BAT2206 is also currently under review by the China National Medicinal Product Administration.
Bio-Thera has previously received approvals for the biosimilars QLETI® (adalimumab) in China (November 2019); TOFIDENCETM/BAT1806 (tocilizumab) in the US (September 2023, with Biogen acquiring all exclusive rights for countries other than China in a deal announced in April 2021), EU (June 2024) and China; and Avzivi®/Pobevcy® (bevacizumab,) in the US (December 2023, marketed by Sandoz) and China.