Bio-Thera Solutions Expands Partnership with Pharmapark in Russia and other CIS Countries with Addition of BAT2206, a Stelara® Biosimilar

On October 15, 2021 Bio-Thera Solutions, Ltd. (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and a pipeline of biosimilars, reported the company has reached licensing and supply agreements with Pharmapark LLC, for BAT2206, its ustekinumab biosimilar, under which Pharmapark will have exclusive rights to distribute and market the drug with a status of a local product in Russia and other CIS countries (Press release, BioThera Solutions, OCT 15, 2021, View Source [SID1234591296]). Bio-Thera and Pharmapark’s partnership was initiated around a licensing and supply agreement for Pharmapark to distribute and market BAT2506, a golimumab biosimilar, in Russia and other CIS countries.

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BAT2206 is a proposed biosimilar to Jansen’s Stelara1 which is currently approved in the U.S. for the treatment of active psoriatic arthritis (PsA) in adults, alone or in combination with MTX, the treatment of patients 6 years or older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy, the treatment of moderately to severely active Crohn’s disease in adults, and the treatment of moderately to severely active ulcerative colitis in adults.

Bio-Thera’s BAT2206 has completed a Phase I study and is currently being evaluated in a global Phase III clinical study including patients from China, Russia and 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). 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 BAT2206 out of its manufacturing facilities in Guangzhou, China.

"Bio-Thera is pleased to expand our partnership with Pharmapark to commercialize our ustekinumab biosimilar program in Russia and other CIS countries", said Dr. Shengfeng Li, CEO of Bio-Thera. "By expanding our partnership with Pharmapark, Bio-Thera is redoubling its commitment to providing Russian patients with increased access to innovative biotherapeutics at affordable prices."

"We are extremely happy to expand our collaboration with Bio-Thera. Pharmapark intends to continue to work with the leading biosimilar developers to enable rapid entrance of biosimilar products to the Russian and CIS markets and strengthen our position in Russia as the leading player in the biosimilar market." said Vyacheslav Lebedyansky, CEO of Pharmapark.