BIOSIMILARS UPDATES

21 APR 2024 | US | Xbrane to Resubmit BLA for Ranibizumab Biosimilar following FDA CRL On 21 April 2024, Swedish biosimilar developer Xbrane announced that the FDA issued a Complete Response Letter (CRL) regarding its BLA for ranibizumab...

12 APR 2024 | US | Six Regeneron Aflibercept US Patent Infringement Actions to be Centralized in West Virginia On 11 April 2024, the United States Judicial Panel on Multijurisdictional Litigation ruled that patent infringement actions brought by...

05 APR 2024 | Samsung Bioepis Commences Phase 3 Trials for Keytruda® Biosimilar On 5 April 2024, Samsung Bioepis announced the commencement of Phase 3 clinical trials for SB27, biosimilar to MSD’s Keytruda® (pembrolizumab) in patients with...

28 MAR 2024 | US | Celltrion Launches US Pediatric High Concentration Adalimumab Biosimilar On 28 March 2024, the Korea IT Times reported the US launch of Celltrion’s pediatric 20mg Yuflyma®, biosimilar to AbbVie’s Humira® (adalimumab), for the...

22 MAR 2024 | AU | Samsung Bioepis Seeks to Revoke Janssen’s Stelara® (ustekinumab) Patents in Australian Court On 22 March 2024, the first case management hearing was held before Justice Nicholas in the Federal Court of Australia, Sydney, in...

15 MAR 2024 | AU | November 2023 PBAC Public Summary Documents Feature Biopharma On 15 March 2024, the Australian Department of Health and Aged Care published the public summary documents considered at the November 2023 PBAC meeting. Decisions...

9 MAR 2024  US | Samsung Bioepis Presents Interchangeability Updates for its Adalimumab and Ustekinumab Biosimilars at AAD On 9 March 2024, Samsung Bioepis presented two papers of study results for its immunology portfolio at the 2024 American...

1 MAR 2024 | AU | Authorities raid Como Compounding Pharmacy in Melbourne and Seize Semaglutide The Australian Financial Review reported that on 1 March 2024 TGA investigators raided Como Compounding Pharmacy in Melbourne and seized ‘off-brand’...