FDA Approves Citrate-Free High-Concentration Humira Biosimilar Hadlima

The FDA has approved the citrate-free, high-concentration 100mg/mL formulation of adalimumab-bwwd (Hadlima; Samsung Bioepis Co Ltd, Organon & Co), a biosimilar referencing adalimumab (Humira; AbbVie Inc), which showed overall survival and safety in patients with multiple disease conditions.

The approval of adalimumab-bwwd was based on clinical data from a randomized, single-blind, single-dose study that compared the pharmacokinetics, safety, tolerability, and immunogenicity of 2 formulations of adalimumab-bwwd (100 mg/mL vs 50 mg/mL) in healthy participants, according to a press release.

“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,” said Byoungin Jung, vice president and regulatory affairs team leader, Samsung Bioepis, 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.”

Adalimumab-bwwd is a tumor necrosis factor blocker indicated for rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn disease, ulcerative colitis, and plaque psoriasis. Additionally, it was previously approved by the FDA as a low-concentration (50 mg/mL) formulation in July 2019; outside the United States, that formulation has been available in various global markets under different brands.

Most of the adverse events (AEs) reported by patients when given adalimumab-bwwd in the recent clinical trials were infections, injection site reactions, headaches, and rash.

“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, Organon, said in a press release. “Today, adalimumab is the largest drug expense in the [United States]. We look forward to making our biosimilar available for those that rely on it to help manage their disease.”

Adalimumab-bwwd will be available in pre-filled syringe and autoinjector options.

REFERENCE

Samsung Bioepis and Organon Announce FDA Approval of Citrate-Free High-Concentration HUMIRA® Biosimilar HADLIMA™ (adalimumab-bwwd). BusinessWire. August 17, 2022. Accessed August 18, 2022. https://www.businesswire.com/news/home/20220816005432/en