On September 3, 2020 Bio-Thera Solutions (688177.SS), a commercial-stage biopharmaceutical company, reported that dosing has begun in a Phase I clinical study to compare the pharmacokinetics and safety of BAT2206, a proposed biosimilar of Stelara (ustekinumab), to US-sourced and EU-sourced reference product in normal healthy volunteers (Press release, BioThera Solutions, SEP 3, 2020, View Source [SID1234564424]). The clinical study will be a randomized, double-blind, parallel group, single-dose study that is expected to enroll approximately 270 healthy volunteers.

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"The initiation of this clinical trial represents an important milestone for our biosimilar pipeline," said Dr. Shengfeng Li, CEO, Bio-Thera Solutions. "BAT2206 is the fifth biosimilar that Bio-Thera has advanced into clinical development. It signifies Bio-Thera’s continued commitment to developing and providing safe, effective, and affordable biological products for patients in China and around the world."

Bio-Thera Solutions is developing several additional biosimilar products, including QLETLI, a biosimilar to Humira, which is approved by the NMPA in China. Bio-Thera’s lead global biosimilar is BAT1706, a biosimilar to Avastin, has completed a global Phase III clinical trial and the BLA has been submitted and accepted by NMPA. Regulatory submissions for BAT1706 to FDA and EMA will occur in 2020Q4. Bio-Thera Solutions is also pursuing biosimilar versions of Actemra, Cosentyx and Simponi.