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.
Bio-Thera and STADA expand biosimilars partnership to include tocilizumab
Shilpa Medicare secures approval for NAFLD therapy NorUDCA in India
Remegen's Telitacicept meets Sjogren's syndrome Phase III trial's primary endpoint
PainReform acquires majority stake in LayerBio to advance dropless cataract surgery therapy
Insmed's BRINSUPRI (brensocatib) non-cystic fibrosis bronchiectasis treatment approved by US FDA
Fosun Pharma agrees XH-S004 overseas licensing deal
Novartis reports positive Phase III results for ianalumab in Sjögren's disease
CivicaScript to distribute biosimilar for chronic inflammatory conditions