Bio-Thera Solutions, a China based biopharmaceutical company, with a pipeline of late-stage biosimilars and innovative therapies, is eyeing the lucrative and flourishing biosimilars market in Russia. Bio-Thera has entered into a licensing agreement with Pharmapark LLC, a Russian pharmaceutical company to give the latter exclusive commercial rights to its golimumab biosimilar (BAT2506) for Russia and Commonwealth of Independent Nations (CIS) countries.
BAT2506 is a biosimilar to Janssen’s Simponi™ which is currently approved for rheumatoid arthritis, active psoriatic arthritis and ankylosis spondilytis in adults. The asset is currently being studied in a phase 1 trial in China and it plans to initiate global phase 3 trials by the fourth quarter of 2020. It intends to submit a regulatory application to the US FDA, EMA and China NMPA in 2023 while Pharmapark will be responsible for seeking approval in Russia and other CIS countries.
Bio-Thera is one among the few rapidly growing Chinese biosimilar companies with global aspirations. The current partnership marks the first of its kind for Bio-Thera to expand its presence in the Russian market. In January it became the first company in China to launch a Humira (adalimumab) biosimilar, and it has a pipeline of several late-stage biosimilars such as tocilizumab, ustekinumab etc.
Earlier in June 2020, Henlius became the first Chinese biosimilar company to receive a positive opinion from EMA’s CHMP on its marketing authorization application for its Trastuzumab biosimilar indicating growing interests of bio-pharma companies from emerging nations in global markets. However, time to market and the pace of development will continue to be key determinants of success and return on investment in the global biosimilar market. Regulated markets such as US and EU, although immensely attractive, are becoming increasingly competitive and ensuring long-term sustainable presence in these markets will become more complex with increasing binary risk leading to enhanced focus on production economics.