FDA Accepts sBLA for Interchangeability Designation for Adalimumab-bwwd

Samsung Bioepis Co., Ltd. and Organon & Co. announced today that the US Food and Drug Administration (FDA) has accepted their Supplemental Biologics License Application (sBLA) for review for the biosimilar interchangeability designation of HADLIMA (adalimumab-bwwd), a biosimilar to Humira (adalimumab).

This filing, submitted in August 2023, marks a step forward in improving patient access to biologic medicines in the United States.

The sBLA submission was supported by clinical data from a phase 4 study (NCT05510063) which examined the pharmacokinetic similarity between 2 treatment groups. The study involved patients with moderate to severe plaque psoriasis who alternated between high-concentration formulations of Humira and HADLIMA, versus those who received Humira continuously.

“An interchangeability designation may play a role beyond enabling pharmacy substitution. We believe that interchangeability could help increase physician confidence with prescribing biosimilars, especially in the high-concentration formulation which is used by the majority of Humira patients. We remain committed to helping more patients access biosimilar alternatives,” said Jon Martin, Head, US Biosimilars at Organon, in a press release.

HADLIMA was initially approved by the FDA in July 2019 as a low-concentration (40 mg/0.8 mL) formulation of prefilled syringe and prefilled autoinjector. In August 2022, the high-concentration (40 mg/0.4 mL) formulation of prefilled syringe and prefilled autoinjector of HADLIMA received FDA approval. The commercial introduction of HADLIMA took place on July 1, 2023, with Organon taking the lead in marketing the biosimilar.

HADLIMA injection 40 mg/0.4 mL and 40 mg/0.8 mL, a tumor necrosis factor blocker, is approved for indications including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa, and uveitis.

"Following our announcement on the interchangeability study's topline results in August, we are excited to share the progress on this sBLA filing on interchangeability. This filing acceptance is a reinforcement of our commitment to provide better access to biologic medicines for patients in the United States," said Byoung In Jung, Vice President and Regulatory Affairs Team Leader at Samsung Bioepis, in a press release. "We will continue to drive our goal of realizing the value of biosimilars for patients and contributing to the sustainability of healthcare systems."

Reference

1. Samsung Bioepis. Samsung Bioepis & Organon announce FDA acceptance of Supplemental Biologics License Application (SBLA) for Interchangeability designation for Hadlima (Adalimumab-bwwd), a biosimilar to Humira. GlobeNewswire News Room. November 7, 2023. Accessed November 7, 2023. https://www.globenewswire.com/news-release/2023/11/07/2775667/0/en/Samsung-Bioepis-Organon-Announce-FDA-Acceptance-of-Supplemental-Biologics-License-Application-sBLA-for-Interchangeability-Designation-for-HADLIMA-adalimumab-bwwd-a-Biosimilar-to-Hu.html