Chinese biotechnology company Bio-Thera Solutions Ltd (SHA:688177) and German pharmaceutical company STADA Arzneimittel AG announced on Friday that they have expanded their biosimilars alliance to include tocilizumab, a monoclonal antibody targeting the interleukin-6 receptor and used in treating inflammatory and autoimmune disorders.
Under the deal, Bio-Thera will oversee development, manufacturing, and supply of the biosimilar referencing Roche's RoActemra, while STADA will hold exclusive commercialisation rights across the European Union, the UK, Switzerland, and other selected markets.
This follows EU-wide marketing authorisation for Bio-Thera's BAT1806 version of tocilizumab in the form of 20mg/ml vials following a positive European Medicines Agency opinion.
The arrangement builds on Bio-Thera and STADA's May 2024 agreement covering BAT2506, a biosimilar candidate to Simponi (golimumab), for which a marketing authorisation application has been accepted by the European Medicines Agency.
Tocilizumab represents a significant commercial opportunity, with global sales of RoActemra/Actemra reaching EUR2.8bn in 2024, including roughly USD700m in Europe despite biosimilar competition.
The partnership agreement is subject to shareholder approval.
Hemogenyx reports positive safety and early efficacy data from third patient in CAR-T trial
Forte Biosciences highlights positive FB102 data in celiac disease at Tampere Symposium
Hemogenyx Pharmaceuticals partners with Made Scientific to advance CAR-T therapy
Onco3R Therapeutics receives Belgian regulatory approval for clinical trial of novel SIK3 inhibitor
ImmuPharma files patent for P140 'Immunormalizer' with precision diagnostic for autoimmune diseases
Coya Therapeutics wins FDA clearance to advance COYA 302 into Phase 2 ALS trial
Bio-Thera and STADA expand biosimilars partnership to include tocilizumab
Abbvie completes Capstan Therapeutics acquisition
Remegen's Telitacicept meets Sjogren's syndrome Phase III trial's primary endpoint
Novartis reports positive Phase III trial results for ianalumab in immune thrombocytopenia
Novartis reports positive Phase III results for ianalumab in Sjögren's disease
US FDA approves Innovent's IND application for IBI3032 oral GLP-1R agonist
Formation Bio licenses IMIDomics' anti-CD226 autoimmune programme
Hemogenyx wins USD120,000 grant to advance scalable CAR-T manufacturing
IGI and AbbVie enter global licensing agreement for ISB 2001