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On 2 July 2024, Eli Lilly announced that the US FDA has approved its KisunlaTM (donanemab-azbt) for early symptomatic Alzheimer’s Disease (patients with mild cognitive impairment or mild dementia stage of disease).  Once-monthly Kisunla is the first amyloid plaque-targeting...

Alvotech announced positive topline results from a confirmatory clinical study for AVT03 (denosumab), biosimilar to Amgen’s Prolia® and Xgeva®. The study, involving 532 postmenopausal women with osteoporosis, met its primary endpoints, demonstrating clinical similarity in e...

According to a corporate disclosure made to the Korean Exchange by Samsung Biologics, the company has entered into its largest contract manufacturing organisation (CMO) deal to date with an unnamed US based pharmaceutical company valued at USD $1.06b. The contract extends u...

Fresenius Kabi has launched its subcutaneous formulation of Tyenne® (tocilizumab-aazg), biosimilar to Roche’s Actemra® (tocilizumab), in the United States.  This new formulation provides patients with primary immunodeficiency diseases a convenient alternative to intravenous...

Checkpoint Therapeutics has announced that it has resubmitted to the FDA its Biologics License Application (BLA) for cosibelimab for metastatic or locally advanced cutaneous squamous cell carcinoma.  The resubmission aims to address “approvability deficiencies” identified i...

On 12 July 2023, Samsung Bioepis UK Limited commenced proceedings against Janssen Biotech Inc in the High Court of Justice of England and Wales seeking to invalidate the UK counterpart patent of European Patent No. EP 3 883 606.  Janssen’s patent relates to the use of ustek...

On 1 July 2024, Amneal Pharmaceuticals and Kashiv Biosciences announced that they have entered into an exclusive licence agreement for the US in relation to ADL018, biosimilar to Genentech’s and Novartis’ Xolair® (omalizumab).    ADL018 was developed by Kashiv and is curren...

On 1 July 2024, South Korea’s Alteogen announced that its subsidiary Altos Biologics submitted a marketing authorisation application (MAA) to the European Medicines Agency (EMA) for its ALT-L9, biosimilar to Regeneron’s Eylea® (aflibercept).  According to the press release,...