China accepts Bio-Thera’s application for tocilizumab copy biological BAT1806

Biosimilars/News | Posted 26/11/2021 post-comment0 Post your comment

China’s National Medical Products Administration (NMPA) has accepted a marketing authorization application for Bio-Thera Solutions’ (Bio-Thera) copy biological of tocilizumab, an immunosuppressant used in the treatment of arthritis.

Rheumatology.org V13H09

On 8 November 2021, Bio-Thera announced that China’s drug regulatory agency had accepted the marketing authorization application for their tocilizumab copy biological, BAT1806.

Tocilizumab is an immunosuppressive drug which acts on the receptor of the inflammatory cytokine receptor, IL-6. It is used for the treatment of inflammatory conditions including rheumatoid arthritis and systemic juvenile idiopathic arthritis and, in the US, was granted emergency use authorization (EUA) for the treatment of COVID-19 in June 2021. It is sold under the brand name Actemra by originator company Roche.

Bio-Thera announced positive phase III data for BAT1806 in June 2021, demonstrating equivalent efficacy and comparable safety to the originator in patients with moderate-to-severe rheumatoid arthritis [1].

In China, Bio-Thera have made Type 3 and 4 patent certifications on Roche’s three patents directed to medical uses. The company is the first copy biological applicant to make a Type 4 patent certification since China released its patent linkage system in July 2021.

The system (Measures for the Implementation of Early Resolution Mechanisms for Drug Patent Disputes (Trial)) is similar to the US system for patent certifications. For registered patents on approved biologicals, copy biological applicants must certify that:
1) There is no relevant patent registered
2) The registered patent has expired or has been declared invalid or the applicant has a licence
3) There is a registered patent, and the biosimilar applicant will not market the drug until the expiration of the patent
4) There is a registered patent, but it is invalid, or the copy biological does not infringe

Bio-Thera have also recently begun phase III trials for copy biologicals of Simponi (golimumab) [2] and Stelara (ustekinumab) [3].

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Patent expiries may drive development of copy biologicals in China

China approving more copy biologicals since new guidelines introduced

Positive phase I results for Bio-Thera’s bevacizumab copy biological

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References
1. GaBI Online - Generics and Biosimilars Initiative. Positive phase III results for tocilizumab biosimilar BAT1806 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Nov 26]. Available from: www.gabionline.net/biosimilars/research/positive-phase-iii-results-for-tocilizumab-biosimilar-bat1806
2. GaBI Online - Generics and Biosimilars Initiative. Clinical trials begin for Bio-Thera’s golimumab copy biological [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Nov 26]. Available from: www.gabionline.net/biosimilars/research/clinical-trials-begin-for-bio-thera-s-golimumab-copy-biological
3. GaBI Online - Generics and Biosimilars Initiative. Bio-Thera and Samsung Bioepis start clinical trials for ustekinumab biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Nov 26]. Available from: www.gabionline.net/biosimilars/news/bio-thera-and-samsung-bioepis-start-clinical-trials-for-ustekinumab-biosimilars

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