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Mar 27, 2025
On 27 March 2025, Chugai (a Roche subsidiary) and Zenyaku Kogyo announced that their co-marketed Rituxan® (rituximab) has been approved by the Japanese Ministry of Health, Labour and Welfare…
Mar 27, 2025
At its March meeting, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted positive opinions for seven indication expansions…
Mar 27, 2025
On 27 March 2025, Gedeon Richter announced that the European Medicines Agency (EMA) has accepted its marketing authorisation application (MAA) for RGB-19, biosimilar to Roche’s…
Mar 27, 2025
On 27 March 2025, MSD announced that the US FDA has accepted its Biologics Licence Application for subcutaneous pembrolizumab (pembrolizumab…
Mar 27, 2025
At its March 2025 meeting, the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions for three new biosimilars…
Mar 27, 2025
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…
Mar 26, 2025
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…
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…
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