The Food and Drug Administration (FDA) has approved a citrate-free, high concentration formulation of 100mg/mL of Hadlima (adalimumab-bwwd), a biosimilar to Humira® (adalimumab).

Hadlima, a tumor necrosis factor (TNF) blocker, is approved for:

  • Rheumatoid arthritis (RA): reducing signs/symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA; may be used alone or with methotrexate (MTX) or other non-biologic DMARDs.
  • Juvenile idiopathic arthritis (JIA): reducing signs/symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older; may be used alone or with MTX.
  • Psoriatic arthritis (PsA): reducing signs/symptoms, inhibiting the progression of structural damage, and improving physical function in patients with active PsA; may be used alone or with non-biologic DMARDs.
  • Ankylosing spondylitis (AS): reducing signs/symptoms in adult patients with active AS.
  • Crohn disease (CD): moderately to severely active CD in patients 6 years of age and older.
  • Ulcerative colitis (UC): moderately to severely active UC in adult patients.
  • Plaque psoriasis (PsO): treating adult patients with moderate to severe chronic PsO who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate.

Hadlima was previously approved by the FDA as a low concentration formulation (50mg/mL) in July 2019 based on data from a double-blind, 52-week phase 3 study that evaluated Hadlima in 544 patients with moderate to severe rheumatoid arthritis despite methotrexate therapy. Results from the study showed that the efficacy and safety of Hadlima was comparable to Humira.

The approval of the new citrate-free, high concentration formulation of Hadlima was based on data from a randomized, single-blind, 2-arm, parallel group, single-dose phase 1 study (ClinicalTrials.gov Identifier: NCT04514796) that compared the pharmacokinetics, safety, tolerability, and immunogenicity of Hadlima 100mg/mL to 50mg/mL in healthy volunteers. 

“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. 

Hadlima will be supplied as a prefilled syringe or PushTouch Autoinjector for subcutaneous injection containing 50mg/mL or 100mg/mL of adalimumab-bwwd. The expected launch date for Hadlima will be on or after July 1, 2023.

Reference

Samsung Bioepis and Organon announce FDA approval of citrate-free high-concentration Humira® biosimilar Hadlima™ (adalimumab-bwwd). News release. Samsung Bioepis Co., Ltd. and Organon & Co. Accessed August 17, 2022. https://www.businesswire.com/news/home/20220816005432/en/Samsung-Bioepis-and-Organon-Announce-FDA-Approval-of-Citrate-Free-High-Concentration-HUMIRA%C2%AE-Biosimilar-HADLIMA%E2%84%A2-adalimumab-bwwd