Positive results were reported from a phase III trial of an adalimumab copy biological, HS016, which compared the candidate adalimumab copy biological HS016 with originator adalimumab Humira for the treatment of active ankylosing spondylitis (AS) [1].
The multicentre, randomized, double-blind, parallel, positive control, phase III clinical study (ChiCTR1900022520) was conducted at 28 locations in China. A total of 648 patients with active AS were randomized in a 2:1 ratio to subcutaneously receive 40 mg of either HS016 (416) or Humira (232) every other week for 24 weeks.
No significant difference was found in the ASAS20* response rates at 24 weeks between the HS016 (364/416, 87.5%) and Humira (209/232, 90.1%) treatments and the difference between the response rates (− 2.59%; 90% confidence interval [CI] − 6.77 to 1.60) was within the predefined equivalence margin (±15%). There were also no significant differences when the secondary endpoints were compared (all p > 0.05).
Similarly, the rates of treatment-emergent adverse events (TEAEs) were not significantly different between the two groups, with most TEAEs being mild to moderate. Only nine severe cases were found, including seven within the HS016 group, three (0.7%) of which were tuberculosis cases.
Plasma concentrations of HS016 and Humira from Weeks 12 to 14 were similar during the steady-state period and steady-state maximal concentration (Cmax,ss) was equivalent for HS016 (7,356.6 ng/mL) and Humira (7,600.3 ng/mL). The accumulated proportion of patients with positive human anti-human antibodies (HAHAs) at Week 24 was 326/412 (79.1%) in the HS016 group and 183/229 (79.9%) in the Humira group (p > 0.05), while the accumulated proportion of patients with positive neutralizing antibody tests were 72/412 (17.5%) in the HS016 group and 43/229 (18.8%) in the Humira group (p > 0.05).
Based on these results, the authors concluded that ‘HS016 resembled adalimumab in efficacy and safety over the 24-week treatment period’. They added that, based on their findings, ‘HS016 should be considered as an affordable alternative for the treatment of Chinese patients with AS’.
HS016, is produced by China-based Hisun Pharmaceuticals (Hisun). The company first reported positive results for HS016 at the European Congress of Rheumatology 2019 (EULAR 2019) [2].
Hisun announced in September 2018, that HS016 had been accepted for review by China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA) [3].
*The ASAS Response Criteria (ASAS 20) is defined as an improvement of at least 20% and an absolute improvement of at least 10 units on a 0−100 scale in at least three of the following domains: Patient global assessment, Pain assessment, Function (BASFI), and Inflammation (last 2 questions of BASDAI − Bath Spondylitis Ankylosing Disease Activity Index).
ASAS 40, 50 and 70 are defined as above with improvements of at least 40%, 50% and 70% respectively.
Conflict of interest
The authors of the research paper [1] declared that there was no conflict of interest. However, it should be noted that the work was supported by Hisun.
Editor’s comment
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.
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References
1. Su J, Li M, He L, et al. Comparison of the efficacy and safety of adalimumab (Humira) and the adalimumab biosimilar candidate (HS016) in Chinese patients with active ankylosing spondylitis: a multicenter, randomized, double-blind, parallel, phase iii clinical trial [published online ahead of print, 2020 Feb 20]. BioDrugs. 2020;10.1007/s40259-020-00408-z. doi:10.1007/s40259-020-00408-z
2. GaBI Online - Generics and Biosimilars Initiative. Positive phase III data for adalimumab copy biologicals [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Apr 10]. Available from: www.gabionline.net/Biosimilars/Research/Positive-phase-III-data-for-adalimumab-copy-biologicals
3. GaBI Online - Generics and Biosimilars Initiative. Adalimumab copy biologicals accepted for review in China [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Apr 10]. Available from: www.gabionline.net/Biosimilars/News/Adalimumab-copy-biologicals-accepted-for-review-in-China
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