2nd Humira Biosimilar Seen as Effective and Safe in Phase 3 Trial in China

Ana Pena, PhD avatar

by Ana Pena, PhD |

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Hulio approved by FDA

HS016, a biosimilar candidate of Humira (adalimumab), was seen to have equivalent safety and effectiveness at treating adults with active ankylosing spondylitis (AS) in a Phase 3 trial in China.

Researchers believe that HS016 could be a less expensive alternative to Humira for AS patients in China, and possibly the second Humira biosimilar approved in that country.

The study “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” was published in the journal BioDrugs.

Humira (marketed by AbbVie) is an antibody that binds to and blocks the effects of a pro-inflammatory molecule called tumor necrosis factor-alpha (TNF-alpha), preventing it from activating the inflammatory responses associated with autoimmune diseases.

The medicine is approved to treat various rheumatic and inflammatory conditions, including AS, where it proved effective against active disease and in improving the physical health and well-being of patients.

A biosimilar is a near-exact copy of a biological medicine with the same basic structure, formulation, and route of administration. It has highly similar chemical properties, potency, pharmacological profile, and activity.

Qletli (marketed by Bio-Thera Solutions) recently became the first biosimilar of Humira available in China.

Hisun Pharmaceuticals is developing HS016 as a new Humira biosimilar. Its Phase 3 trial at 28 sites across that country  (ChiCTR1900022520) assessed the two compounds’ equivalence.

The trial enrolled 648 adults with active AS, with a mean age of 32.

Participants were randomly assigned to either 40 mg of HS016 (416 patients) or Humira (232 patients), given by under-the-skin injections every other week for 24 weeks.

Effectiveness was primarily defined by the ASAS20 response rate — the proportion of patients who achieved at least a 20% improvement (reduction) in three or more key domains — physical function, pain, patient global assessment, and inflammation — after 24 weeks of treatment.

No significant difference in response rates was seen between HS016 (87.5%) and Humira (90.1%). The risk difference between the two groups (2.59%) fell within the predefined margin of 15%. “This finding demonstrated the clinical equivalence between HS016 and adalimumab [Humira],” the researchers wrote.

Secondary measures were also comparable between the two therapies, including response rates at week 12 (79.6% with HS016 vs. 81.0% with Humira), ASAS40 (requires at least 40% improvement) response, disease activity scores (BASDAI), severity of morning stiffness, and patient-reported physical and mental health.

Safety profiles were also similar, with 84.6% of HS016-treated patients and 86.2% of those on Humira experiencing treatment-emergent adverse events. Most were mild to moderate.

Nine people had severe side effects — seven in the HS016 group, three of which (0.7%) were cases of tuberculosis.

Results of blood and urine work, heart exams (electrocardiography), vital-sign assessments, and physical examinations were also similar between the HS016 and Humira groups.

Likewise, the number of positive cases for anti-therapy antibodies — antibodies raised against biologic compounds that may render a therapy less effective — were equivalent between patient groups at week 24

Both compounds also showed a similar pharmacokinetic profile — the absorption, and distribution of a substance within the body, and its elimination — with equivalent peak concentrations in blood (7356.6 ng/mL with HS016 vs. 7600.3 ng/mL with Humira).

“HS016 was similar to adalimumab [Humira] in efficacy and safety,” the researchers concluded. “Based on our findings, HS016 should be considered as an affordable alternative for the treatment of Chinese patients with AS.”