The citrate-free high-concentration formulation and citrate-containing low-concentration of biosimilar adalimumab-bwwd are now available to patients living in the US.
Organon and Samsung Bioepis announced the United States (US) launch of the adalimumab biosimilar, adalimumab-bwwd (HADLIMA), on July 1, 2023. The tumor necrosis factor inhibitor (TNF) is used to treat patients with chronic autoimmune diseases including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, plaque psoriasis, ankylosing spondylitis, ulcerative colitis, and Crohn’s disease.1
The citrate-free high-concentration formulation (100 mg/mL) of adalimumab-bwwd was previously approved by the US Food and Drug Administration (FDA) in August 2022 and is also available in a citrate-containing low-concentration (50 mg/mL). The drug, which is administered using pre-filled pens (PushTouch autoinjector) or pre-filled syringes, is now available at list price ($1038), which represents a discount of 85% in comparison with the reference product.
“As the largest loss-of-exclusivity event in pharmaceutical history, this is a singular moment for the US health care system to embrace biosimilars,” said Kevin Ali, Chief Executive Officer of Organon, in a statement. “Every stakeholder should be invested in the success of this market to realize the value biosimilars can create for patients, providers, and the US health care economy.”
Designed with the patient in mind, the autoinjector pen was awarded the Arthritis Foundation’s Ease of Use Certification. It offers a latex-free needle cover, buttonless device with a sure-grip shape, and a thin 29G needle.
In addition to its easy-to-use design, Organon and Samsung Bioepis created the “HADLIMA For You” patient support program, in which patients can receive educational resources, including a co-pay program, and dedicated nurse coaches. Patients enrolled in the program will experience individualized care designed to fit their unique needs.
The 2022 FDA approval decision was based on a randomized, single-blind, 2-arm, parallel group, single-dose study evaluating the safety, tolerability, immunogenicity, and pharmacokinetics of adalimumab-bwwd 50 mg/mL and adalimumab-bwwd 100 mg/mL in 188 healthy male patients (mean age 38.4 years).
Immunogenicity, which was evaluated using the occurrence of anti-drug antibodies and neutralizing antibodies, was comparable between both treatment arms. The mean values and ranges of pharmacokinetics parameters, tolerability, and treatment-emergent adverse events (TEAEs) were similar for both low- and high-concentration groups. The most common TEAEs in patients receiving the biosimilar (>10%) were upper respiratory infections, sinusitis, headache, rash, and injection site reactions. No TEAE led to study discontinuation and all reported events were mild or moderate in severity.
Patients receiving TNF blockers, including adalimumab products, may be at a higher risk of developing lymphoma and other malignancies. They are also at an increased risk of developing serious infections, particularly when receiving concomitant immunosuppressant treatment.
Physicians should consider the risks and benefits of initiating treatment in patients with chronic or recurrent infection, a history of opportunistic infection, underlying conditions that may predispose them to infection, and those exposed to tuberculosis.
“We are thrilled to now provide adalimumab-bwwd in the US at a more affordable cost and expand much-needed access to adalimumab,” Ali wrote. “With our deep biosimilar commercial experience, a new comprehensive patient support program, and our dedication to providing exceptional healthcare provider support, we are immediately well-positioned to make a positive impact.”