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Jan 20, 2025
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 and indications for nAMD, diabetic macular oedema (DME), visual impairment due to myopic choroidal neovascularisation (CNV), and macular oedema following retinal vein occlusion (RVO).
Jan 18, 2025
On 18 January 2025, Daiichi Sankyo announced that Daiichi/Astra Zeneca’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 who have received prior endocrine-based therapy and chemotherapy. According to Daiichi, the drug will be available in the US by prescription in approximately two weeks.
Jan 17, 2025
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 weight loss at week 72 with semaglutide 7.2 mg versus placebo, with patients treated with the high dose semaglutide achieving weight loss of 20.7% compared to a reduction of 17.5% with semaglutide 2.4 mg and a reduction of 2.4% with placebo.
Jan 17, 2025
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...
Jan 16, 2025
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.
Jan 16, 2025
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®.
Jan 16, 2025
On 16 January 2025, Outlook Therapeutics announced 12-week results of its NORSE EIGHT clinical trial evaluating ONS-5010 (LytenavaTM, ophthalmic bevacizumab) in wet AMD. The results are said to show that ONS-5010 demonstrated non-inferiority to Genentech’s Lucentis® (ranibizumab) in terms of efficacy and safety.
Jan 16, 2025
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...
Jan 16, 2025
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...
Jan 16, 2025
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 metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) Exon 19 deletions or Exon 21 L858R substitution mutations, whose disease has progressed on or after treatment with osimertinib.
Jan 15, 2025
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, moderately to severely active ulcerative colitis, moderate to severe plaque psoriasis and active psoriatic arthritis.
Jan 15, 2025
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.
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