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Bio-Thera gains Chinese approval for adalimumab copy biological and starts ustekinumab trial Posted 13/12/2019

China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA) has approved Qletli, an adalimumab copy biological. The NMPA has also approved the Investigational New Drug (IND) application from Bio-Thera Solutions (Bio-Thera) to initiate a phase I clinical study for the proposed ustekinumab copy biological BAT2206.

Qletli (格乐立) was developed by China-based Bio-Thera and the company announced on 7 November 2019 that the product had been approved for all eligible indications of the reference biological, Humira (adalimumab). The approved indications include treatment of three autoimmune diseases: rheumatoid arthritis, ankylosing spondylitis and plaque psoriasis.

The approval of Qletli by the NMPA was based on the totality of evidence from a comprehensive data package supporting biosimilarity to adalimumab which includes analytical, non-clinical, pharmacokinetics, pharmacodynamics and clinical data. The phase III clinical study met its primary endpoint showing no clinically meaningful differences in safety, immunogenicity and efficacy compared to adalimumab.

The approval of Qletli marks Bio-Thera’s first copy biological to receive regulatory approval.

Bio-Thera also announced on 4 December 2019 that the NMPA had approved its IND application to initiate a phase I clinical trial for its proposed ustekinumab copy biological, BAT2206.

The phase I clinical study will compare the pharmacokinetics and safety of BAT2206 versus the US- and EU-sourced reference product, Stelara (ustekinumab), in normal healthy volunteers. The clinical study will be a randomized, double-blind, parallel group, single-dose study that is expected to enrol approximately 270 healthy volunteers.

Bio-Thera is developing several proposed copy biologicals, including versions of Avastin (bevacizumab) [1] and Actemra/RoActemra (tocilizumab) [2], which are both currently being evaluated in global phase III clinical trials. The company is also pursuing copy biologicals of Humira (adalimumab) [2], Simponi (golimumab) [2] and Stelara (ustekinumab).

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

References
1. GaBI Online - Generics and Biosimilars Initiative. Positive phase I results for Bio-Thera’s bevacizumab copy biological [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Dec 13]. Available from: www.gabionline.net/Biosimilars/Research/Positive-phase-I-results-for-Bio-Thera-s-bevacizumab-copy-biological
2. 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 2019 Dec 13]. Available from: www.gabionline.net/Biosimilars/Research/Positive-results-for-Bio-Thera-s-arthritis-copy-biologicals

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