Bio-Thera Solutions Targets Russia for Golimumab Biosimilar

Guangzhou, China—based Bio-Thera Solutions has signed a marketing agreement for its golimumab biosimilar candidate (BAT2506) with Russian biopharmaceutical company Pharmapark, based in Moscow.

BAT2506 is a proposed biosimilar to Jansen’s Simponi, which is indicated for adults for the treatment of moderate to severe rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis.

The agreement gives Pharmapark exclusive distribution and marketing rights for BAT2506 in Russia and other Commonweath of Independent States (CIS) countries.

“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,” Vyacheslav Lebedyansky, CEO of Pharmapark, said in a statement.

Since 2019, the golimumab biosimilar is currently being tested in a phase 1 clinical trial, and Bio-Thera plans for the candidate to undergo a phase 3 trial by the fourth quarter of 2020. The phase 3 trial will include patients from Russia, China, and other countries.

Bio-Thera intends to submit an application for regulatory approval with China’s National Medical Products Administration (NMPA), the European Medicines Agency, and the FDA in 2023. Pharmapark will be responsible for filing for approval in all CIS countries.

Besides Russia, CIS countries are Armenia, Azerbaijan, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Tajikistan, Turkmenistan, Ukraine, and Uzbekistan.

Russia’s Budding Biosimilar Industry

In a recent interview with The Center for Biosimilars^®, Roman Drai, MD, PhD, the deputy director and head of clinical operations at Geropharm, another Russian biopharmaceutical company, discussed how Russia’s biosimilar industry has grown over the past decade.

In 2010, the Russian government enacted the Pharma 2020 initiative, which involved an increase in grants for biopharmaceutical companies to create a certain amount of generic and biosimilar drugs in addition to originator molecules.

Drai said the plan was so successful that the government decided to create a new program called Pharma 2030 that will have a larger focus on creating originator drugs.

Bio-Thera Solutions sees Russia as a potentially lucrative market. “This partnership is the first to expand Bio-Thera’s presence into Russia, an important pharmaceutical market for biosimilars and innovative drugs,” said Shengfeng Li, company CEO.

As companies like Bio-Thera hope to break into the growing Russian market, Drai explained that Russian companies, such as Pharmapark and Geropharm, seek to branch out into more mature international markets, including Europe, Latin American and the Far East. However, he explained that slow biosimiar acceptance in the United States and anticompetitive practices make the nation less attractive to expanding companies.

Bio-Thera’s Biosimilar Pipeline

In June 2020, Bio-Thera’s application for its bevacizumab biosimilar (BAT1706) candidate was accepted for review by the NMPA. The company seeks to market the drug for the treatment of certain colorectal and lung cancers.

The company’s adalimumab biosimilar (Qletli) received marketing approval in China and launched there in January 2020.

In addition to BAT2506, Bio-Thera is conducting a phase 1 clinical trial for an ustikinumab biosimilar candidate and is pursuing biosimilar versions of tocilizumab (Actemra) and secukinumab (Cosentyx), among others.