A Chinese biopharma company called Bio-Thera Solutions has begun the testing of its first batch of healthy volunteers to compare the safety and pharmacokinetics of BAT2506, proposed as a biosimilar of Simponi (Janssen) with EU-sourced Simponi in healthy volunteers.
The Phase I clinical trial for BAT2506, a biosimilar of Simponi, marks the fourth biosimilar that the company has advanced into clinical trials. Bio-Thera focuses on developing safe and effective biosimilars for patients worldwide.
The Phase I BAT2506 study is expected to enroll 182 healthy participants, each of whom will be given a single subcutaneous dosage of either EU-sourced Simponi or BAT2506.
The Chinese emerging biopharma is developing a variety of innovative drugs and biosimilars, such as versions of Actemra/RoActema (Roche) and Avastin (Genentech), which are being evaluated in global Phase III clinical trials. Moreover, they are working on versions of Stelara (Janssen) and BAT1406 for Humira (AbbVie).
Deal with Cipla
In early 2019, the company inked a deal with Cipla, an Indian multinational pharmaceutical company, to obtain exclusive rights to market and distribute its bevacizumab biosimilar—BAT1796 used in the treatment of non-small lung cancer for emerging markets.
The Cipla deal offers robust local presence, market capabilities and sales channel in emerging markets. Bio-Thera has been responsible for the development and product registration process with the FDA and EMA along with commercial supply of BAT1706 from its manufacturing facilities in China.
Cipla is generating close to $4 billion in revenues.
About Bio-Thera Solutions
Founded in 2003 and based in Guangzhou, China, they are a leading emerging biopharma focusing on research and development of novel therapeutics in targeted therapeutic areas, including cardiovascular disease, autoimmune, cancer and other critical unmet needs. It has progressed five candidates to late-stage clinical trials. Moreover, the firm develops biosimilars for prevailing, branded biologics to treat autoimmune diseases and cancer.
The company has multiple promising candidates in IND-enabling studies and early clinical trials targeting innovative new products in autoimmune and immune-oncology diseases.