Bio-Thera Initiates P-I Study of BAT2206 Proposed Biosimilar to Stelara (ustekinumab)
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- The first patient has been dosed in a P-I clinical study to compare the PK and safety of BAT2206- a proposed biosimilar to Stelara (ustekinumab) to US/EU-sourced reference product in healthy volunteers
- The company is expected to enroll 270 healthy volunteers. BAT2206 represents the fifth biosimilar of Bio-Thera’s portfolio that has advanced into clinical development
- BioThera is developing additional products- including QLETLI (biosimilar to Humira)- which is approved in China- BAT1706 (biosimilar to Avastin)- that has completed a P-III study with expected regulatory submission in Q4’20. The company is also pursuing biosimilar versions of Actemra- Cosentyx- and Simponi
Ref: BioThera | Image: Long Term Care Rx
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