On 9 March 2024, Samsung Bioepis presented two papers of study results for its immunology portfolio at the 2024 American Academy of Dermatology (AAD) Annual Meeting being held from March 8 to 12 in San Diego, California, United States.
For its Humira® biosimilar (adalimumab/SB5), Samsung Bioepis presented further information relating to its Phase 4 (switching) study results, which formed the basis of its sBLA seeking interchangeability filed in November 2023. Results from the same trials were published in Ocular Immunology and Inflammation in January 2024, and in the BMJ Open Opthalmology in December 2023. Hadlima™ is FDA approved and has been supplied in the US since 1 July 2023 under a licence from AbbVie entered into in 2018.
For SB17, biosimilar to Janssen’s Stelara® (ustekinumab), Samsung Bioepis presented the Phase 3 results for SB17 with switching studies, which demonstrated efficacy, safety, and immunogenicity for 52 weeks. These results were presented at ECCO last month.
SB5/Hadlima™ is commercialised in the US by Organon. SB17 will be commercialised by Sandoz in the US, Canada, EEA, Switzerland and the UK under an exclusive commercialisation agreement inked in September 2023.