Health Canada has approved the high-concentration version of Samsung Bioepis and Organon’s Hadlima, a citrate-free adalimumab biosimilar referencing Humira.
Samsung Bioepis announced the Canadian approval of its high-concentration (HC), citrate-free formulation of its biosimilar referencing Humira (adalimumab). Hadlima HC was developed through a commercialization agreement between Samsung Bioepis and Organon.
The approval comes almost 4 years after Health Canada’s initial approval of the low-concentration version of Hadlima (SB5) in May 2018. Both concentrations of Hadlima will be used in the treatment of a number of rheumatic conditions, including rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, ankylosing spondylitis, psoriatic arthritis, Crohn disease, ulcerative colitis, hidradenitis suppurativa, plaque psoriasis, and uveitis.
“We are pleased to receive Health Canada approval of our high concentration adalimumab biosimilar, marking a key milestone for us now to have both a low and high concentration adalimumab biosimilar approved in Canada….The latest approval reflects our continuous efforts to meet the needs of our patients and bring more treatment options available,” commented Byoungin Jung, vice president and leader of the Regulatory Affairs Team at Samsung Bioepis, in a statement.
Health Canada’s decision on the new formulation was based on data from a phase 1 clinical trial assessing the pharmacokinetics (PK), safety, and tolerability of the new formulation (40 mg/0.4 mL) compared with the low-concentration version (40 mg/0.8 mL) in healthy male subjects. The study established equivalent PK between both versions, which were also found to be well tolerated by the participants and had similar safety profiles.
More Updates on Samsung Bioepis Biosimilars
The approval follows Samsung Bioepis’ announcing updates to its studies surrounding proposed biosimilars for Soliris (eculizumab), Prolia/Xgeva (denosumab), and Stelara (ustekinumab). The data for SB12 (eculizumab biosimilar) were shared at the American Society of Hematology Annual Meeting (ASH), which occurred at the tail end of 2022 in New Orleans, Louisiana.
The company announced the completion of phase 3 studies assessing SB17 (ustekinumab biosimilar) and SB16 (denosumab biosimilar) compared with their originators in patients with moderate to severe plaque psoriasis and female patients with osteoporosis, respectively.
Samsung Bioepis originally published data on SB12 at the European Hematology Association Congress (EHA) in June 2022 but shared additional data at ASH 2022. The phase 3 study on SB12 demonstrated equivalent safety, PK, pharmacodynamic, and immunogenicity profiles between the biosimilar and Soliris in patients with paroxysmal nocturnal hemoglobinuria.
The primary end points were the level of lactate dehydrogenase (LDH) at week 26 and time-adjusted area of under the effect curve of LDH from week 14 to week 36 and from week 40 to week 52. The results showed that the endpoints between the biosimilar and the originator fell within the predefined equivalence margin (34.48; 95% CI, –47.66 to 116.62).
Researchers also conducted a sensitivity analysis, which showed consistent results and validated the study’s robustness, further supporting the therapeutic equivalence between the 2 drugs.
“We are fully aware that rare diseases, such as PNH pose many, but unique, challenges to patients and their families. We will continue our journey to transform the way biologic therapies are brought to patients and enhance the lives of patients, including those with rare diseases, through our pioneering and innovative use of science and technology,” said Luke Oh, PhD, vice president and product evaluation team leader at Samsung Bioepis, in a statement on the original data in June 2022.