Samsung Bioepis and Organon announced the US Food and Drug Administration (FDA) approval of the citrate-free, high-concentration (100 mg/mL) formulation of adalimumab-bwwd (HADLIMA), a biosimilar of adalimumab (HUMIRA), for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, plaque psoriasis, ankylosing spondylitis, and Crohn’s disease. The high-concentration version of adalimumab-bwwd, first approved by the FDA as a low-concentration (50 mg/mL) dose in July 2019, will be available in both autoinjector and pre-filled syringe options.
“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, Samsung Bioepis, stated. “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.”
The decision was based on a randomized, single-blind, two-arm, parallel group, single-dose study that evaluated the safety, tolerability, immunogenicity, and pharmacokinetics of adalimumab-bwwd 50 mg/mL and adalimumab-bwwd 100 mg/mL in healthy male subjects (n = 188, mean age 38.4 years).
Immunogenicity, assessed by 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 cohorts. The most common TEAEs were upper respiratory infection, sinusitis, injection site reactions, headaches, and rash. No TEAE led to study discontinuation and all reported events were mild or moderate in severity.
“Today, adalimumab is the largest drug expense in the US,” Joe Azzinaro, Vice President, Global Commercial Lead Biosimilars, Organon, stated. “We look forward to making our biosimilar available for those that rely on it to help manage their disease.”