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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, including to:

BMS’ Opdivo® (nivolumab) in combination with platinum-based chemotherapy ...

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 RoActemra® (tocilizumab).  This follows Gedeon’s announcement of positive topline results from Ph...

On 27 March 2025, MSD announced that the US FDA has accepted its Biologics Licence Application for subcutaneous pembrolizumab (pembrolizumab plus berahyaluronidase alfa), with indications across all previously approved solid tumour indications for Keytruda®.  The FDA has se...

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.

Accord Healthcare’s Jubereq® and Osvyrti®, biosimilars to Amgen’s Xgeva® and Prolia® (denosumab) respe...

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 available from US Costco Specialty Pharmacies from 1 April 2025 for self-funded employer...

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, biosimilar to Genentech/Novartis’ Xolair® (omalizumab)...

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 Stelara® (ustekinumab) and Simponi® (golimumab), respectively.

Under the...

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 Prolia® and Xgeva® respectively, for all reference indications.  Fresenius is the fourth sponso...

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) in adults whose disease is ...