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Denosumab copy biological clinical trial application accepted in China Posted 27/03/2020

China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA), has accepted a clinical trial application of denosumab copy biological HLX14.

China-based Shanghai Henlius Biotech (Henlius) announced on 9 March 2020 that the clinical trial application of its proposed denosumab copy biological HLX14 had been accepted by the NMPA. The product is a copy biological of Amgen’s Prolia/Xgeva (denosumab), which is indicated for the treatment of bone resorption and postmenopausal osteoporosis.

Henlius says that HLX14, which ‘is a recombinant anti-receptor activator of nuclear factor kappa B ligand (RANKL) human monoclonal antibody (mAb) injection’, has been ‘developed in accordance’ with China’s guidelines for copy biologicals, which were released in February 2015 [1].

HLX14 can specifically bind to RANKL and block the interaction between RANKL and RANK, which is expressed on the surface of osteoclasts, thus inhibiting RANKL/RANK-mediated differentiation, maturation and activation of osteoclasts, thereby reducing bone resorption and the incidence of skeletal-related events.

Henlius is working on several copy biologicals, and its portfolio includes several advanced mAb candidates, which the company says are close to commercialization.

The company’s rituximab copy biological Hanlikon (HLX01 [汉利康]) was approved in China in March 2019 [2]. Its adalimumab (HLX03) and trastuzumab (HLX02) candidate copy biologicals currently have their applications under priority review with the NMPA. While HLX02 was accepted for review by the European Medicines Agency (EMA) in June 2019, as the first biosimilar developed in China to be accepted for review in Europe [3].

Henlius is also working on a bevacizumab copy biological, HLX04 [4], and a pertuzumab copy biological, HLX22 [5].

Editor’s comment
It should be noted that copy biologicals approved in China might not have been authorized following as strict a regulatory process as is required for approval of biosimilars in the European Union. The EMA (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.

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Biosimilars of denosumab

References
1. GaBI Online - Generics and Biosimilars Initiative. Chinese guidelines for copy biologicals [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Mar 27]. Available from: www.gabionline.net/Guidelines/Chinese-guidelines-for-copy-biologicals
2. GaBI Online - Generics and Biosimilars Initiative. China approves rituximab copy biological [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Mar 27]. Available from: www.gabionline.net/Biosimilars/News/China-approves-rituximab-copy-biological
3. GaBI Online - Generics and Biosimilars Initiative. EMA accepts first application for Chinese-made biosimilar HLX02 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Mar 27]. Available from: www.gabionline.net/Biosimilars/News/EMA-accepts-first-application-for-Chinese-made-biosimilar-HLX02
4. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of bevacizumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Mar 27]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-bevacizumab
5. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of pertuzumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Mar 27]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-pertuzumab

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Source: Henlius

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