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On 16 January 2025, Samsung Bioepis published its quarterly US Biosimilar Market Report.  The report has been released every quarter since April 2023 and details average sales price information for US launched biosimilars and market share and price trends.

The Q1/202...

On 16 January 2025, Bio-Thera announced that it has signed an exclusive licence and commercialisation agreement with Turkish company, World Medicine, in relation to Bio-Thera’s BAT2206 (ustekinumab), biosimilar to Janssen’s Stelara®.

Under the terms of the agreement,...

On 16 January 2025, Outlook Therapeutics announced 12-week results of its NORSE EIGHT clinical trial evaluating ONS-5010 (Lytenava™, ophthalmic bevacizumab) in wet AMD.  The results are said to show that ONS-5010 demonstrated non-inferiority to Genentech’s Lucentis® (ranibi...

On 16 January 2025, AIS Health reported that Amgen has launched Wezlana® (ustekinumab), biosimilar to J&J/Janssen’s Stelara® in the US through Optum Health Solution’s private label subsidiary Nuvaila.  The biosimilar is said to have been launched on 1 January 2025 and i...

On 16 January 2025, UCB announced that it has launched in the US a high dose presentation of Bimzelx® (bimekizumab-bkzx) in a single-injection 2 mL prefilled syringe and autoinjector, each containing 320 mg of Bimzelx®.  This is in addition to the currently available 1 mL (...

On 16 January 2025, Johnson & Johnson (J&J) announced that Health Canada has approved its Rybrevant® (amivantamab for injection) in combination with standard of care chemotherapy (carboplatin and pemetrexed) for the treatment of patients with locally advanced or met...

On 15 January 2025, Formycon and Fresenius Kabi announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved FYB202/Otulfi®, biosimilar to J&J/Janssen’s Stelara® (ustekinumab), for moderately to severely active Crohn’s disease, moderatel...

On 15 January 2025, Eli Lilly announced that the US FDA has approved Omvoh® (mirikizumab-mrkz) for the treatment of moderately to severely active Crohn’s disease in adults.  This follows FDA approval of Omvoh® for ulcerative colitis in October 2023.

In August 2...