Bio-Thera Reports NMPA’s Acceptance of IND for BAT2206 Proposed Biosimilar of Stelara (ustekinumab)

Bio-Thera Reports NMPA’s Acceptance of IND for BAT2206 Proposed Biosimilar of Stelara (Ustekinumab)

Shots:

  • Bio-Thera to initiate P-I study to evaluate the PK and safety study of BAT2206 (proposed biosimilar) vs Janssen’s Stelara (ustekinumab) US & EU-sourced in normal healthy candidates
  • The clinical study will enroll ~ 270 healthy volunteers. The initiation of the study implies Bio-Thera’s commitment to develop & commercialize biosimilars for patients across the globe including China
  • Bio-Thera’s biosimilar portfolio includes Qletli (referencing Humira), BAT1706 (referencing Avastin) and is also working on biosimilar versions of Actemra, Cosentyx and Simponi. BAT2206 will be the fifth biosimilar in Bio Thera’s portfolio to be advance into clinical development

Click here to­ read full press release/ article | Ref: PRNewswire | Image: Bio-Thera