BAT2506 is a proposed biosimilar to Jansen’s Simponi® which is currently approved for the treatment of moderately to severely active rheumatoid arthritis (RA) in adults, in combination with methotrexate (MTX), active psoriatic arthritis (PsA) in adults, alone or in combination with MTX and active ankylosing spondylitis (AS) in adults.
Bio-Thera’s BAT2506 will begin a global Phase III study in patients with PsA in Q4 of 2020. The Phase III global clinical study will include patients from China, Russia and many other countries. Bio-Thera intends to file for regulatory approval with the China National Medical Products Administration (NMPA), the European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA) in 2023. Pharmapark will be responsible for filing the dossier in Russia and other CIS countries.
This partnership will leverage Pharmapark’s strong local presence, sales and marketing capabilities in Russia and other CIS countries. Bio-Thera will be responsible for full development, and commercial supply of BAT2506 out of its manufacturing facilities in Guangzhou, China.
“Bio-Thera is pleased to partner with Pharmapark to commercialize our golimumab biosimilar program in Russia and other CIS countries”, said Dr. Shengfeng Li, CEO of Bio-Thera. “This partnership is the first to expand Bio-Thera’s presence into Russia, an important pharmaceutical market for biosimilars and innovative drugs.”
“Partnership with Bio-Thera is an integral part of our strategy to expand our biosimilar portfolio by partnering with the leading biosimilar developers. This agreement represents an important milestone for Pharmapark, and for our patients in Russia and CIS countries that will soon benefit from an increased access to high quality affordable medicines.” said Vyacheslav Lebedyansky, CEO of Pharmapark.
About Bio-Thera Solutions
Bio-Thera Solutions, Ltd., a leading commercial-stage biopharmaceutical company in Guangzhou, China, is dedicated to researching and developing novel therapeutics for the treatment of cancer, autoimmune, cardiovascular diseases, and other serious unmet medical needs, as well as biosimilars for existing, branded biologics to treat a range of cancer and autoimmune diseases. As a leader in the next generation antibody discovery and engineering, the company has advanced five candidates into late stage clinical trials and one of which, QLETLI® (格乐立®), a biosimilar to Humira® (adalimumab), is available to patients with
rheumatoid arthritis, ankylosing spondylitis, or plaque psoriasis in
China. In addition, the company has multiple candidates in early
clinical trials and IND-enabling studies, focusing on innovative targets
in immuno-oncology and autoimmune diseases. For more information,
please visit www.bio-thera.com/en/ or follow us on Twitter (@bio_thera_sol) and wechat (Bio-Thera).
About Pharmapark LLC:
Pharmapark is a privately-owned Russian biopharmaceutical company that is focused on development, manufacture and commercialization of biosimilar products. The company possesses the know-how and has a successful track record performing complete biotechnological drug development through commercial production. Pharmapark has successfully marketed 5 biosimilar products and has in-house pipeline of novel formulations and biosimilars focused on value-adding treatments.
1 Simponi ® is a registered trademark of Johnson & Johnson Corporation
2 Humira® is a registered trademark of AbbVie Biotechnology Ltd.
3 QLETLI® is a registered trademark of Bio-Thera Solutions, Ltd.