Before prescribing HADLIMA, please read the accompanying Prescribing Information, including the Boxed Warning about serious infections and malignancies. The Medication Guide and Instructions for ...

The FDA approved the first high-concentration adalimumab biosimilar. A low-concentration version of the biosimilar, Hadlima, was already approved. Both versions will launch in July 2023.

The US Food and Drug Administration today approved a citrate-free, high-concentration formulation of adalimumab-bwwd (Hadlima), the manufacturer, Samsung Bioepis, and its commercialization partner ...

These interchangeability designations follow the interchangeability designation received for the Hadlima low-concentration (40 mg/0.8 ml) prefilled syringe and single-dose vial in June 2024.

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 ...

Hadlima first received FDA approval in 2019 as a 50 mg/mL prefilled syringe or prefilled autoinjector. A higher-concentration 100 mg/mL formulation was later approved in August 2022.

Samsung Bioepis & Organon Announce FDA Acceptance of Supplemental Biologics License Application (sBLA) for Interchangeability Designation for HADLIMA™ (adalimumab-bwwd), a Biosimilar to Humira® ...

The U.S. Department of Veterans Affairs will replace Humira with the biosimilar Hadlima on its national formulary, according to a press release from Organon, which markets biosimilar. Hadlima ...

Before prescribing HADLIMA, please read the accompanying Prescribing Information, including the Boxed Warning about serious infections and malignancies. The Medication Guide and Instructions for ...

Initiate treatment for latent TB prior to HADLIMA use. Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis.