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

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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


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