Bio-Thera Solutions commences Phase 1 study for Simponi® biosimilar
Category: #health  By Pankaj Singh  Date: 2019-08-16
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Bio-Thera Solutions commences Phase 1 study for Simponi® biosimilar

Bio-Thera Solutions, a China based pharmaceutical company, has reportedly announced the start of dosing of its first batch of healthy volunteers in order to compare the safety and pharmacokinetics of BAT2506, proposed as a biosimilar of Simponi (golimumab), with EU-sourced Simponi in healthy volunteers.

According to Shengfeng Li, CEO at Bio- Thera, the phase 1 clinical trial for BAT2506, which is a biosimilar of Simponi, marks the fourth biosimilar that the company has advanced into clinical trials. Bio-Thera aims at facilitating safe and effective biosimilars to patients globally, he further added.

For the record, Bio- Thera Solutions is developing varied proposed biosimilars such as versions of Actemra/ RoActemra and Avastin which are being evaluated in global phase III clinical trials presently. Additionally, biosimilar versions of Stelara and Humira are also being developed.

Earlier in January 2019, the company had signed an agreement with Cipla to gain exclusive rights to market and distribute its bevacizumab biosimilar – BAT1706 used in the treatment of non-small cell lung cancer, in emerging markets.

The alliance was to leverage Cipla’s robust local presence, market capabilities and sales in the emerging markets. Bio-Thera on the other hand was responsible for the complete development and product registration process with the FDA and EMA along with commercial supply of BAT1706 from its manufacturing unit in China.

Reportedly, the Phase 1 BAT2506 study is expected to enroll 182 healthy volunteers, each of whom will be given a single subcutaneous dosage of either EU- sourced Simponi or BAT2506.

Bio-Thera Solutions is a leading biotechnology company which focuses on research and development of novel therapeutics in the diagnosis of cardiovascular diseases, autoimmune, cancer and other critical unmet diseases. Additionally, the firm develops biosimilars for prevailing, branded biologics to treat autoimmune diseases and cancer.

Furthermore, the company has multiple promising candidates in IND- enabling studies and early clinical trials aimed at innovative targets in autoimmune and immune-oncology diseases. 

 

Source Credits:

https://www.businesswire.com/news/home/20190814005245/en/Bio-Thera-Solutions-Initiates-Phase-Clinical-Trial-BAT2506



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Pankaj Singh

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Pankaj Singh

Pankaj Singh Develops content for Market Size Forecasters, Algosonline, and a couple of other platforms. A Post Graduate in Management by qualification, he worked as an underwriter in the UK insurance domain before deciding to switch his field of profession. With exp...

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