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On 5 February 2025, Shanghai Henlius Biotech announced that Hetronifly® (serplulimab) was approved by the European Commission for use in combination with carboplatin and etoposide as a first line treatment of adult patients with extensive-stage small cell lung cancer (ES-SC...

On 5 February 2025, Formycon announced that its partner, Klinge Biopharma, has entered an exclusive licence agreement with Taiwan-based Lotus Pharmaceutical for the commercialisation of FYB203/Ahzantive®, biosimilar to Regeneron’s Eylea® (aflibercept) in the following Asia ...

On 4 February 2025, Cytiva subsidiary media supplier HyClone Laboratories filed a motion in the US District Court for the District of Utah, seeking to quash a subpoena issued to it by Amgen in the context of denosumab BPCIA patent infringement litigation Amgen commenced aga...

On 4 February 2025, Genentech (a member of the Roche group) announced that the US FDA approved a new indication for Susvimo® (ranibizumab, 100mg/ml injection).  Susvimo® is the first and only approved continuous delivery treatment for diabetic macular oedema (DME), the lead...

On 3 February 2025, Johnson & Johnson (J&J) announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended an indication extension for its subcutaneous Rybrevant® (amivantamab):

in combination with...

Shanghai Henlius Biotech announced on 2 February 2025 that the US FDA has accepted its Biologics Licence Application (BLA) for HLX11, biosimilar to Roche’s Perjeta® (pertuzumab).

The US acceptance of Henlius’ BLA follows the December 2024 acceptance of its NDA for HL...

On 31 January 2025, Celltrion announced that the US FDA has approved its Avtozma™/CT-P47, biosimilar to Roche’s Actemra® (tocilizumab), in both subcutaneous and intravenous formulations for several indications, including rheumatoid arthritis (RA), giant cell arteritis (GCA)...

On 31 January 2025, Sanofi announced that China’s National Medical Products Administration (NMPA) has approved Sanofi’s Sarclisa® (isatuximab) in combination with bortezomib, lenalidomide, and dexamethasone (VRd), for the treatment of adult patients with newly diagnosed mul...