US biotechnology company Biogen Idec (Biogen) and China-based Bio-Thera announced on 1 June 2021 positive phase III data for their tocilizumab biosimilar, BAT1806. According to the two companies, ‘the comparative study met its primary endpoints and showed equivalent efficacy and comparable safety profile in patients with moderate-to-severe rheumatoid arthritis’.
The phase III, multicentre, multinational, randomized, double-blind, parallel-group, active-control study (NCT03830203) was designed to compare the efficacy, safety, immunogenicity, and pharmacokinetics of BAT1806 compared with originator tocilizumab (RoActemra) in subjects with rheumatoid arthritis that is inadequately controlled by methotrexate. The study enrolled 621 patients who were randomized to receive either BAT1806 or Actemra.
The primary efficacy endpoint of the study was the percentage of participants with an American College of Rheumatology 20% (ACR20) response over a 6-month period. The secondary endpoint was change from baseline in Disease Activity Score 28-joint count (DAS28) over a 1-year period. Other outcome measures included percentage of participants with an ACR20, ACR50 and an ACR70 response over 1 year.
Ian Henshaw, Head of Global Biosimilars at Biogen said that ‘biosimilars have the potential to generate cost savings, healthcare sustainability and, if approved, BAT1806 would enable us to bring an additional therapeutic option to patients’.
This is the third time Bio-Thera is reporting positive phase III results for its products. It reported positive results for its adalimumab copy biological (BAT1406) in 2019 . The company received Chinese approval for the product, which is marketed as Qletli, in November 2019 and launched it in China in February 2020 . The company also announced positive phase III results for its bevacizumab copy biological (BAT1706) in February 2020 . The company has since submitted applications for approval of BAT1706 to both the European Medicines Agency (EMA)  and the US Food and Drug Administration (FDA) .
Biogen and Bio-Thera announced a commercialization and license agreement in April 2021 to develop, manufacture and commercialize BAT1806. Biogen has exclusive regulatory, manufacturing and commercial rights to BAT1806 in all countries excluding China (including Hong Kong, Macau and Taiwan).
Biosimilars of tocilizumab
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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 2021 Jun 11]. 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 2021 Jun 11]. 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 2021 Jun 11]. Available from: www.gabionline.net/Biosimilars/Research/Positive-results-for-Bio-Thera-s-bevacizumab-copy-biological
4. GaBI Online - Generics and Biosimilars Initiative. EMA accepts application for bevacizumab biosimilar BAT1706 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Jun 11]. Available from: www.gabionline.net/Biosimilars/News/EMA-accepts-application-for-bevacizumab-biosimilar-BAT1706
5. GaBI Online - Generics and Biosimilars Initiative. FDA accepts application for bevacizumab biosimilar BAT1706 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Jun 11]. Available from: www.gabionline.net/Biosimilars/News/FDA-accepts-application-for-bevacizumab-biosimilar-BAT1706
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Source: Biogen, ClinicalTrials.gov