On 27 March 2025, Celltrion announced that its Steqeyma®, biosimilar to J&J’s Stelara® (ustekinumab), has been added to the US Costco Member Prescription Program. Steqeyma® will be…
On 26 March 2025, Alvotech, Kashiv Biosciences and Advanz Pharma announced that the UK Medicines and Healthcare Products Regulatory Agency (MHRA) has accepted its application for marketing authorisation (MAA) for AVT23…
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…
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…
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)…
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…
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…
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…
On 19 March 2025, the US FDA approved MSD’s Keytruda® (pembrolizumab) with trastuzumab, fluoropyrimidine- and platinum- containing chemotherapy for the first-line treatment…
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%…
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)…
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®…
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…
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…
On 13 March 2025, Celltrion announced that Steqeyma® (CT-P43), biosimilar to J&J’s/Janssen’s Stelara® (ustekinumab), is now available in the US for the treatment of psoriatic arthritis, plaque…
On 12 March 2025, New Zealand’s Pharmac announces that it has entered an agreement with Pfizer to fund a range of drugs from 1 April 2025, including its Besponsa® (inotuzumab ozogamicin) for the…