China-based biopharmaceutical company Bio-Thera Solutions (Bio-Thera) announced on 18 July 2020 that it has signed a licensing agreement for its proposed golimumab biosimilar BAT2506 with Russia-based Pharmapark.
BAT2506 is a proposed biosimilar to Janssen’s Simponi (golimumab), which is currently approved as a treatment for adults with moderate to severe rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis (PsA). A phase I trial of BAT2506 has been ongoing since 2019 [1], and Bio-Thera plans to begin a global phase III clinical trial in the fourth quarter of 2020 to assess BAT2506 as a treatment for patients with PsA.
Under the new agreement, Russian biopharmaceutical company Pharmapark will have exclusive rights to distribute and market BAT2506 with the status of a local product in Russia as well as other Commonwealth of Independent States (CIS) countries. Bio-Thera will be responsible for development and commercial supply of BAT2506 from its manufacturing facilities in Guangzhou, China. Bio-Thera intends to file for regulatory approval with the China National Medical Products Administration (NPMA), the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) in 2023. Pharmapark will be responsible for filing for approval 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 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’.
Vyacheslav Lebedyansky, CEO of Pharmapark, said in a statement: ‘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’.
Bio-Thera launched the first adalimumab copy biological (Qletli) in China in January 2020 [2]. In June, the NMPA agreed to review Bio-Thera’s application for its bevacizumab copy biological candidate (BAT1706) following positive results from a phase III trial [3].
Editor’s comment
European Medicines Agency regulatory requirements ensure the same high standards of quality, safety and efficacy for biosimilars as for originator biologicals, and also include a rigorous comparability exercise with the reference product but they are not universally accepted by regulatory bodies outside of the European Union (EU). It should be noted that copy biologicals approved in China might not have been authorized if they had been subjected to the strict regulatory processes required for approval of biosimilars in the EU.
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References
1. GaBI Online - Generics and Biosimilars Initiative. Positive results for Bio-Thera’s arthritis copy biologicals [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Sep 4]. Available from: www.gabionline.net/Biosimilars/Research/Positive-results-for-Bio-Thera-s-arthritis-copy-biologicals
2. GaBI Online - Generics and Biosimilars Initiative. Bio-Thera launches first adalimumab copy biological in China [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Sep 4]. Available from: www.gabionline.net/Biosimilars/News/Bio-Thera-launches-first-adalimumab-copy-biological-in-China
3. GaBI Online - Generics and Biosimilars Initiative. Positive results for Bio-Thera’s bevacizumab copy biological [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Sep 4]. Available from: www.gabionline.net/Biosimilars/Research/Positive-results-for-Bio-Thera-s-bevacizumab-copy-biological
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