On 16 July 2025, Bio-Thera Solutions announced that the FDA has accepted for review its Biological Licence Application (BLA) for BAT2506, biosimilar to J&J’s Simponi® (golimumab). BAT2506 is being
On 16 July 2025, the US District Court for the District of New Jersey made consent orders reflecting a settlement of the patent infringement litigation brought by Amgen against Accord and Intas relating to Accord/Intas’ biosimilar denosumab
On 15 July 2025, Biocon Biologics announced that the FDA has approved Kirsty™ (insulin aspart-xjhz) as the first and only interchangeable biosimilar to Novo Nordisk’s Novolog®.
On 14 July 2025, Samsung Bioepis published a whitepaper entitled “Solving the Biosimilar Void in Europe”, which proposes various recommendations for European biosimilar policy reform.
On 11 July 2025, Ono Pharma announced that Korea’s Ministry of Food and Drug Safety has approved an indication extension for Opdivo® (nivolumab) in combination with Yervoy® (ipilimumab)
On 10 July 2025, Formycon announced that it has completed patient enrolment for its clinical study, “Dahlia”, which is comparing the pharmacokinetics, safety and tolerability of FYB206
On 9 July 2025, the Amsterdam District Court ruled that the Pharmaceutical Accountability Foundation (PAF) lacked standing in its collective claim against AbbVie regarding the sale of Humira®
On 9 July 2025, Alvotech announced that it has acquired Switzerland-headquartered Ivers Lee Group to expand its capacity for assembly and packaging and support its growth plans. According to
On 9 July 2025, Samsung Bioepis’ denosumab biosimilars, Ospomyv® and Xborso® (SB16), biosimilars to Amgen’s Prolia® and Xgeva® respectively, were approved by Australia’s Therapeutic Goods
On 9 July 2025, Lupin Limited and Zentiva Group announced that they have entered into a global licence and supply agreement for the commercialisation of Lupin’s certolizumab pegol biosimilar
On 8 July 2025, Celltrion announced the US launch of Stoboclo® and Osenvelt® (CT-P41), biosimilars to Amgen’s Prolia® and Xgeva® (denosumab), respectively. Celltrion is the third sponsor to launch
On 7 July 2025, Biocon announced that it has received marketing authorisations from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for its denosumab products Evfraxy® and Vevzuo®
On 4 July 2025, The Bio reported that Korea’s Ministry of Food and Drug Safety has approved Celltrion’s Phase 3 clinical trial plan (IND) for CT-P44, biosimilar to Johnson & Johnson’s Darzalex®…
Over the last week, the European Commission (EC) has approved denosumab biosimilars for three sponsors…
On 2 July 2025, The Economic Times reported that Aurobindo Pharma’s wholly owned subsidiary, CuraTeq Biologics, has received marketing approval from the European Commission for Dazublys®…
On 2 July 2025, Sunshine Biopharma announced that its wholly owned Canadian subsidiary, Nora Pharma, has launched Niopeg®, biosimilar to Amgen’s Neulasta® (pegfilgrastim) in Canada. Niopeg®…