FDA Approves Higher Concentration of Hadlima, a Humira Biosimilar

New formulation, to be marketed by Organon, will reach US market in 2023

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by Lindsey Shapiro |

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The U.S. Food and Drug Administration (FDA) has approved a new, more highly concentrated formulation of Hadlima (adalimumab-bwwd), a biosimilar to AbbVie’s Humira (adalimumab), for the treatment of ankylosing spondylitis.

As a biosimilar, Hadlima has similar properties, safety, and efficacy to an approved biological treatment, in this case Humira. Similarly to generic forms of lab-made medications, biosimilars are typically sold at lower prices than their reference medication.

Developed by Samsung Bioepsis, Hadlima was approved in the U.S. for ankylosing spondylitis in 2019 at a concentration of 50 mg/mL. The newly approved formulation will be a higher concentration: 100 mg/mL.

Hadlima is delivered to the body as an under-the-skin injection. While both formulations are designed to deliver the same amount of the active ingredient (40 mg), the more concentrated version will deliver it in a smaller volume of the solution it’s carried in.

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Organon will market the newly approved formulation in the U.S. Both concentrations are expected to launch after July 1, 2023.

Other indications for Hadlima include rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, Crohn’s disease, ulcerative colitis, and plaque psoriasis.

“With this approval, we now have both a low and high concentration adalimumab biosimilar approved by the FDA, marking an important step towards expanding treatment options for patients suffering from certain chronic, autoimmune diseases,” Byoungin Jung, vice president and regulatory affairs team leader of Samsung Bioepsis, said in a press release.

“By leveraging our development expertise, manufacturing excellence and supply chain reliability, we will continue our work to ensure healthcare systems have more affordable treatment options available,” Jung added.

Hadlima is an antibody-targeting tumor necrosis factor (TNF), a major player in the inflammatory cascades involved in several inflammatory diseases, including ankylosing spondylitis and rheumatoid arthritis. By inhibiting TNF, Hadlima is thought to prevent new inflammation and ease existing inflammation in the joints of ankylosing spondylitis patients.

Findings from a Phase 3 clinical trial (NCT02167139), which compared the safety and efficacy of Hadlima to Humira, supported the initial approval of Hadlima’s lower concentration.

The trial enrolled 544 patients with moderate to severe rheumatoid arthritis who failed to respond to another treatment. Participants were randomized to receive Hadlima or Humira, both injected under the skin at a 40 mg dose.

Data showed that the safety, efficacy and immunogenicity — the ability for a medication to generate an immune response — were comparable between the two medications. No adverse effects were seen when patients were switched from Humira to Hadlima.

The new concentration

Approval of the 100 mg/mL concentration was supported by data from a Phase 1 clinical trial (NCT04514796), which compared the safety, tolerability, immunogenicity, and pharmacokinetics — a treatment’s movement into, through, and out of the body — of the two Hadlima concentrations in 188 healthy male volunteers.

Data showed that the safety, pharmacokinetic, and immunogenic profiles of the two concentrations were similar.

Hadlima will be available as a pre-filled syringe or an autoinjector. The higher concentration, which requires less fluid to be injected, is also thought to make administration easier. It will also be citrate-free. Citrates are sometimes added to medications to stabilize their pH, but that can make injections more painful.

Due to Humira’s patent protections, no Humira biosimilars have yet entered the U.S. market.

Humira biosimilars, including the low dose of Hadlima, have been available in other parts of the world, including Europe, Canada, and Australia. More than 5 million doses of Hadlima have been sold since 2018.

“Based on our success commercializing our adalimumab biosimilar in other markets around the world, combined with our established presence in the biosimilar space, we are excited about the opportunity to launch HADLIMA in the US in 2023,” Joe Azzinaro, vice president, global commercial lead biosimilars at Organon, said.

“Today, adalimumab is the largest drug expense in the US. We look forward to making our biosimilar available for those that rely on it to help manage their disease,” he added.