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The FDA designated Hadlima as an interchangeable biosimilar to Humira, enhancing patient access and potential savings for various conditions.
The FDA has granted interchangeability designation to Hadlima (adalimumab-bwwd; Samsung Bioepis, Organon), a biosimilar to Humira (adalimumab; AbbVie), as a high- and low-concentration autoinjector and a high-concentration prefilled syringe.1
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“Hadlima, now designated as fully interchangeable with the reference product, has a greater potential to bring savings for patients. As our data show, on average, patients paid more than 4 times as much out of pocket per month for Humira compared to Hadlima," Jon Martin, US commercial lead, biosimilars, and established brands at Organon, said in a news release.1
As a tumor necrosis factor (TNF) blocker, Hadlima is indicated for various conditions, including rheumatoid arthritis (RA), alone or in combination with methotrexate or other nonbiologic disease-modifying antirheumatic drugs (DMARDs); juvenile idiopathic arthritis for adults with moderate to severe active RA, alone or in combination with methotrexate in individuals 2 years or older; psoriatic arthritis, alone or in combination with nonbiologic DMARDs; ankylosing spondylitis; Crohn disease in adults or pediatric patients 6 years and older; moderate to severe ulcerative colitis; moderate to severe chronic plaque psoriasis who are candidates for systemic therapy and phototherapy; moderate to severe hidradenitis suppurativa; and noninfectious intermediate, posterior, and panuveitis uveitis.1
Currently, Hadlima is available as an interchangeable biosimilar for Humira in 40-mg/0.4-mL and 40-mg/0.8-mL autoinjectors and high-concentration prefilled syringes. This new indication follows the June 2024 interchangeable designation Hadlima received for the 40-mg/0.8-mL prefilled syringe and single-dose vial.1
An interchangeable biosimilar is a type of biosimilar that can be substituted for the reference product at the pharmacy level without consulting the prescriber, depending on state laws. Both biosimilars and interchangeable biosimilars meet the same FDA standards for safety and effectiveness, and the interchangeability designation does not imply a higher quality or greater efficacy.4
“Both biosimilars and interchangeable biosimilars are highly similar and have no clinically meaningful differences in safety, purity, and potency compared to the reference product,” Byoung In Jung, vice president and regulatory affairs team leader at Samsung Bioepis, said in a news release.1
Hadlima was granted interchangeability to its reference product based on clinical trial data from a randomized, double-blind, 1:1 ratio, parallel-group, multiple-dose phase 3 study (NCT02167139), which evaluated the safety, efficacy, tolerability, pharmacokinetics, and immunogenicity of Hadlima and high-concentration SB5 compared with Humira among individuals with moderate to severe RA despite methotrexate therapy.1,2
Individuals included in the study experienced moderate to severely active RA and were randomly assigned to receive S85 or a 40-mg subcutaneous dose of the reference product every other week.3
The results demonstrated that at week 24, the American College of Rheumatology 20% improvement criteria (ACR20) response rate was equivalent between the SB5 and reference groups at 72.4% and 72.2%, respectively. Additionally, the SB5 and reference groups also displayed comparable results across various end points, including ACR50% and ACR70% response rates, disease activity score, primary pharmacokinetic (PK) data, adverse events, and antibody drug responses.3
The most common adverse reactions in clinical trials for adalimumab include upper respiratory infections, sinusitis infections, injection site reactions, headache, and rash.1
The findings suggest that individuals treated with Hadlima showed comparable PK end points, efficacy, safety, and immunogenicity profiles. Additionally, the study authors noted that other studies further support the interchangeability designation for Hadlima’s low- and high-concentration autoinjectors.1
The interchangeability of Hadlima offers pharmacists and health care providers further treatment options for all its approved indications, allowing pharmacists to substitute Humira with Hadlima. Commonly, the pharmacists do not need to consult the prescriber before switching from the reference biologic product, as permitted by state pharmacy laws.1
“With this approval, pharmacies can substitute HADLIMA for the reference product Humira without consulting prescribers (subject to state law), which may facilitate increased access for patients to receive the medications they need,” Martin concluded in a news release.1
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