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Mar 26, 2025
On 26 March 2025, Bio-Thera Solutions and Dr Reddy’s announced that they have entered exclusive commercialisation and licence agreements for BAT2206 and BAT2506, biosimilars to J&J/Janssen’s…
Mar 26, 2025
On 26 March 2025, Fresenius Kabi announced that the US FDA approved its Biologics Licence Application (BLA) for Conexxence® and Bomyntra® (denosumab-bhnt), biosimilars to Amgen’s…
Mar 25, 2025
On 28 March 2025, Sanofi and Regeneron announced that Japan’s Ministry of Health, Labour and Welfare has granted marketing and manufacturing authorisation for Dupixent® (dupliumab) for the treatment of chronic obstructive pulmonary disease (COPD)…
Mar 24, 2025
On 24 March 2025, GSK announced that the European Medicines Agency (EMA) has accepted for review its application to expand the use of Nucala® (mepolizumab) as an add-on maintenance…
Mar 20, 2025
On 20 March 2025, Johnson & Johnson (J&J) announced that the US FDA has approved Tremfya® (guselkumab) for adult patients with moderately to severely active Crohn’s disease. According to…
Mar 20, 2025
On 20 March 2025, Alvotech announced its acquisition of Xbrane’s Swedish R&D operations, as well as biosimilar candidate XB003 referencing UCB’s Cimzia® (certolizumab pegol). Xbrane will retain…
Mar 19, 2025
On 19 March 2025, the US FDA approved MSD’s Keytruda® (pembrolizumab) with trastuzumab, fluoropyrimidine- and platinum- containing chemotherapy for the first-line treatment…
Mar 19, 2025
On 19 March 2025, Korea Biomedical Review (KBR) reported that Daewoong Pharmaceutical has launched Celltrion’s Stoboclo® (CT-P41), biosimilar to Amgen’s Prolia® (denosumab) at a 28%…
Mar 18, 2025
In a joint press release on 18 March 2025, Alvotech and Dr Reddy’s announced that the US FDA has accepted their Biologic Licence Application (BLA) for AVT03, biosimilar to Amgen’s Prolia® and Xgeva® (denosumab)…
Mar 14, 2025
Australia’s Therapeutic Goods Administration (TGA) has updated its online list of prescription medicines for evaluation for February 2025. Among the applications to be reviewed is a new indication for MSD’s Keytruda®…
Mar 14, 2025
On 14 March 2025, the US Court of Appeals for the Federal Circuit upheld the ruling of the District Court for the Northern District of Virginia refusing Regeneron’s application for a preliminary injunction…
Mar 13, 2025
On 13 March 2025, Business Wire reported that Lumicera Health Services has entered into a purchase agreement with Anda, Inc., a Teva subsidiary, for unbranded ustekinumab, biosimilar to…
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