China-based drugmaker Shanghai Henlius Biotech (Henlius) announced on 27 May 2020 that China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA), had accepted an investigational new drug application (IND) for HLX4, a denosumab copy biological.
Denosumab is a humanized monoclonal antibody that is an inhibitor of the receptor activator of nuclear factor kappa-B ligand (RANKL), which works by preventing the development of osteoclasts which are cells that break down bone. It is used for the treatment of osteoporosis, treatment-induced bone loss, metastases to bone and giant cell tumour of bone.
HLX14 was developed independently by Henlius, which is a subsidiary of the Fosun Pharma Group. The NMPA has approved an IND and clinical trial application for HLX14  for the treatment of postmenopausal women with osteoporosis at high risk for fracture.
Henlius says that it has developed this product ‘in accordance with Chinese Biosimilar Guidelines and EMA Guideline on Similar Biological Medicinal Products’. The company adds that ‘HLX14 has been developed strictly following the principles of stepwise development, comparability and similarity assessment’. Henlius says that HLX14 has been compared with the originator drug, Amgen’s Prolia/Xgeva (denosumab), ‘via a series of head-to-head preclinical studies’. As a result, the company states that ‘HLX14 was shown to be in high similarity to denosumab in preclinical pharmacology, toxicology and pharmacokinetic studies, suggesting potential benefits for osteoporosis patients at high risk of fracture’.
The product pipeline for Henlius includes several monoclonal antibody products that are expected to be commercialized in the near future. The company’s rituximab copy biological, Hanlikon [汉利康 (HLX01], which was developed by subsidiary Shanghai Fuhong Hanlin Bio-Pharmaceutical, was approved by the NMPA in February 2019  and has been launched commercially. Henlius also has NMPA approval for its trastuzumab (HLX02) copy biological and in May 2020 also received a positive recommendation from the European Medicines Agency . In addition, HLX03 (adalimumab) is under review by the NMPA and is expected to be launched during 2020. Henlius also submitted an application for approval to China’s NMPA for its monoclonal antibody copy biological HLX22 in November 2018 .
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.
China publishes draft guideline for denosumab copy biologicals
Biosimilars of denosumab
1. GaBI Online - Generics and Biosimilars Initiative. Denosumab copy biological clinical trial application accepted in China [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jun 12]. Available from: www.gabionline.net/Biosimilars/News/Denosumab-copy-biological-clinical-trial-application-accepted-in-China
2. GaBI Online - Generics and Biosimilars Initiative. China approves rituximab copy biological [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jun 12]. Available from: www.gabionline.net/Biosimilars/News/China-approves-rituximab-copy-biological
3. GaBI Online - Generics and Biosimilars Initiative. EMA recommends approval of trastuzumab biosimilar Zercepac [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jun 12]. Available from: www.gabionline.net/Biosimilars/News/EMA-recommends-approval-of-trastuzumab-biosimilar-Zercepac
4. GaBI Online - Generics and Biosimilars Initiative. Monoclonal antibody copy biologicals accepted for review in China [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jun 12]. Available from: www.gabionline.net/Biosimilars/News/Monoclonal-antibody-copy-biologicals-accepted-for-review-in-China
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