China-based drugmaker Shanghai Henlius Biotech (Henlius) announced on 13 January 2021 that the investigational new drug (IND) application for its daratumumab copy biological, HLX15, had been accepted by China’s drug regulator, the National Medical Products Administration (NMPA), allowing it to carry out clinical trials in the country.
Daratumumab is an anticancer medication. It is used as a treatment for multiple myeloma as it binds to CD38, which is overexpressed in multiple myeloma cells. Multiple myeloma is the second most common haematologic malignancy and accounts for approximately 10% of all haematologic malignant cases.
HLX15 is being developed for the single-agent treatment of adult patients with recurrent and refractory multiple myeloma, as well as for the treatment of first-line, second-line and above multiple myeloma patients. According to estimates from IQVIA, total sales of daratumumab worldwide reached US$2.8 billion, indicating a huge medical need for this drug.
Henlius says that HLX15 has been developed in accordance with the Guidelines for the NMPA’s Technical Guidelines of Development and Evaluation of Biosimilar Drugs and the European Medicine Agency’s (EMA) Guideline on Similar Biological Medicinal Products. The company adds that HLX15 has been developed ‘strictly following the principles of stepwise development, comparability and similarity assessment’. It has also been compared head-to-head with reference daratumumab via analytical studies and preclinical studies. The results of these studies, according to Henlius, ‘showed that HLX15 is highly similar to reference daratumumab’.
Henlius already has two copy biologicals approved in China. The company’s rituximab copy biological Hanlikon (HLX01 [汉利康]) was approved in China in March 2019 and its trastuzumab copy biological Han Quyou (HLX02) was approved in August 2020 . The company is also working on other copy biologicals. The application for its adalimumab (HLX03) candidate copy biological is currently under priority review with the NMPA and the clinical trial application for its denosumab copy biological (HLX14) was accepted by the NMPA in May 2020 . HLX02 was also approved by the European Commission, as Zercepac, in July 2020, making it the first biosimilar developed in China to be approved in Europe .
Henlius is also working on a bevacizumab copy biological, HLX04  and a pertuzumab copy biological, HLX22 . Henlius announced on 29 January 2021 that it had received approval from Australia’s Therapeutic Goods Administration (TGA) to start a two-part phase III global clinical trial to evaluate the efficacy and safety of HLX04 in the treatment of wet age-related macular degeneration (wAMD) . The company says that it has already carried out a series of studies, including non-clinical pharmacodynamics, safety pharmacology, repeat-dose toxicity, pharmacokinetics, toxicokinetics, immunotoxicity, immunogenicity and local irritation of HLX04-O vitreous injection in the treatment of wAMD.
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 non-originator biologicals approved only outside of Europe might not have been authorized if they had been subjected to the strict regulatory processes required for approval of biosimilars in the EU.
EU approves Henlius copy biologicals facility in China
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1. GaBI Online - Generics and Biosimilars Initiative. Copy biologicals approved in China [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Mar 12]. Available from: www.gabionline.net/Biosimilars/General/Copy-biologicals-approved-in-China
2. GaBI Online - Generics and Biosimilars Initiative. China accepts IND application for denosumab copy biological HLX14 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Mar 12]. Available from: www.gabionline.net/Biosimilars/News/China-accepts-IND-application-for-denosumab-copy-biological-HLX14
3. GaBI Online - Generics and Biosimilars Initiative. EC approval for trastuzumab biosimilar Zercepac [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Mar 12]. Available from: www.gabionline.net/Biosimilars/News/EC-approval-for-trastuzumab-biosimilar-Zercepac
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5. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of pertuzumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Mar 12]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-pertuzumab
6. GaBI Online - Generics and Biosimilars Initiative. FDA accepts application for bevacizumab biosimilar BAT1706 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Mar 12]. Available from: www.gabionline.net/Biosimilars/News/FDA-accepts-application-for-bevacizumab-biosimilar-BAT1706
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