Canada OKs High-concentration Hadlima Biosimilar Formulation

US FDA cleared high-dose adalimumab formulation last year

Margarida Maia PhD avatar

by Margarida Maia PhD |

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An illustration marking a regulatory approval.

Health Canada has approved a high-concentration formulation of Hadlima (adalimumab-bwwd), a biosimilar to Humira (adalimumab), for treating ankylosing spondylitis (AS) and other diseases.

A biosimilar is a medical product designed to be identical — with similar properties, as well as comparable safety and effectiveness — to an original name-brand biological therapy. It’s manufactured by a different company and usually sold at lower prices, however. Similar to generics, biosimilars introduce more competition into the pharmaceutical marketplace, helping to reduce medication costs.

Hadlima, developed by Samsung Bioepsis, was approved in Canada in 2018 at a low dose (40 mg/0.8 mL) for treating inflammatory diseases such as AS and other arthritic diseases, inflammatory bowel diseases, as well as conditions that feature skin and eye inflammation.

With the recent approval, it will be available at a high-concentration formulation of 40 mg/0.4 mL. This will deliver the same amount of adalimumab (40 mg), but use a smaller volume of the medication (0.4 mL). It also has no citrate in its composition, which, together with the smaller volume, is expected to make injections less painful and increase treatment compliance.

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Organon will market both formulations, with the high-concentration formulation expected to reach the market later this year.

The two are also approved in the U.S., after U.S. Food and Drug Administration cleared the high-dose formulation in August 2022.

“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,” said Byoungin Jung, vice president and regulatory affairs team leader at Samsung Bioepis, in a company press release.

“The latest approval reflects our continuous efforts to meet the needs of our patients and bring more treatment options available,” Jung said.

Adalimumab is an antibody that binds to and blocks TNF-alpha, a molecule produced by immune cells that play a key role in several inflammatory diseases. By doing so, the medicine is expected to prevent or ease the long-lasting and damaging inflammation that affects the joints with AS.

Samsung Bioepis’ formulation was approved based on findings from a Phase 3 clinical trial (NCT02167139) where low-concentration Hadlima was shown to be highly similar to the reference medicine, Humira.

The new, high-concentration formulation approval was supported by data from a Phase 1 clinical trial (NCT04514796) that compared the safety and immunogenicity (ability to stimulate an immune response) of the two Hadlima concentrations in up to 188 healthy male volunteers. It also tested Hadlima’s pharmacokinetics, or how it moves into, through, and out of the body, as an injection under the skin from a pre-filled syringe or autoinjector.

Data showed the two concentrations were similar in safety, immunogenicity, and pharmacokinetics. Both were also well tolerated, although injection site reactions were less frequent with the high concentration.