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®…
On 2 July 2025, Navlin Daily reported that the Spanish Ministry of Health issued a tender for the sustainable supply of biologics and biosimilars under a two-year Framework Agreement worth…
On 2 July 2025, Apotex announced that Aflivu™, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept, 2mg), has been approved by Health Canada in pre-filled syringe and vial formats. Aflivu™ is…
On 1 July 2025, Sandoz announced that it has commenced construction of a new biosimilar production centre in Brnik, Slovenia, due to open in 2028. Sandoz is investing USD 440 million in the…
On 1 July 2025, Formycon announced that Bioeq AG, which holds the exclusive worldwide commercialisation rights for Formycon’s FYB201, biosimilar to Genentech’s Lucentis® (ranibizumab)…
On 1 July 2025, Pharma Japan reported that Celltrion will launch Steqeyma® (CT-P43), biosimilar to J&J/Janssen’s Stelara® (ustekinumab), in Japan on 8 July 2025…
On 1 July 2025, Fresenius Kabi announced the US launch of Conexxence® and Bomyntra®, biosimilars to Amgen’s Prolia® and Xgeva® (denosumab), respectively. Fresenius’ denosumab biosimilars are…
On 1 July 2025, Samsung Bioepis and Hanmi Pharmaceutical announced that they have jointly launched Obodence™, biosimilar to Amgen’s Prolia® (denosumab), in South Korea, at a 13% cost…
On 1 July 2025, Alvotech and Advanz Pharma announced that the companies have entered into a European supply and commercialisation agreement for AVT10, Alvotech’s biosimilar to UCB’s…
On 1 July 2025, Kexing Biopharm announced via LinkedIn that Pakistan’s Drug Regulatory Authority has granted marketing approval to Arketin™, biosimilar to Roche/Genetech’s Avastin®
On 30 June 2025, Amgen filed BPCIA litigation against Biocon in the in the US District Court for the District of Massachusetts, Eastern Division, asserting infringement of 34 US patents covering…
The results of a phase I study published in Annals of Medicine is said to have established biosimilarity between Beijing SL Pharmaceuticals’ pertuzumab biosimilar, KM118, and the reference product…
On 27 June 2025, Bayer announced that the European Commission has granted a label extension for Eylea™ 8mg (aflibercept, 114.3mg/ml solution for injection) with extended treatment intervals of up to 6 months…