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On 20 January 2025, Formycon and Klinge Biopharma announced that FYB203/Ahzantive®/Baiama® (aflibercept), biosimilar to Regeneron/Bayer’s Eylea®, has been granted marketing approval by the European Commission.  The approval covers all countries in the European Economic Area...

On 18 January 2025, Daiichi Sankyo announced that Daiichi/AstraZeneca’s antibody drug conjugate Datroway® (datopotamab deruxtecan-dlnk) has been approved in the US for treatment of adults with unresectable or metastatic hormone receptor positive HER2 negative breast cancer ...

On 17 January 2025, Novo Nordisk announced results of its Phase 3b trial (STEP UP) of subcutaneous semaglutide 7.2 mg compared with semaglutide 2.4mg and placebo, each administered once weekly.  The results reportedly demonstrate a statistically significant and superior wei...

On 17 January 2025, Junshi Biosciences announced that Australia’s Therapeutic Goods Administration (TGA) has approved Tuoyi® (toripalimab) for the treatment of adults with recurrent unresectable or metastatic nasopharyngeal carcinoma (NPC) with disease progression on or aft...

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 (...