Read our latest updates & insights

On 9 July 2025, the Amsterdam District Court ruled that the Pharmaceutical Accountability Foundation (PAF) lacked standing in its collective claim against AbbVie regarding the sale of Humira® (adalimumab) in the Netherlands, finding that PAF did not hold the requisite inter...

On 9 July 2025, Alvotech announced that it has acquired Switzerland-headquartered Ivers Lee Group to expand its capacity for assembly and packaging and support its growth plans.  According to Alvotech, the acquisition of Ivers Lee will provide “added flexibility and capacit...

On 9 July 2025, Samsung Bioepis’ denosumab biosimilars, Ospomyv® and Xborso® (SB16), biosimilars to Amgen’s Prolia® and Xgeva® respectively, were approved by Australia’s Therapeutic Goods Administration (TGA), for all reference indications.

Samsung Bioepis is the thi...

On 9 July 2025, Lupin Limited and Zentiva Group announced that they have entered into a global licence and supply agreement for the commercialisation of Lupin’s certolizumab pegol biosimilar referencing UCB’s Cimzia®.

Under the agreement, Lupin is responsible for dev...

On 8 July 2025, Celltrion announced the US launch of Stoboclo® and Osenvelt® (CT-P41), biosimilars to Amgen’s Prolia® and Xgeva® (denosumab), respectively.  Celltrion is the third sponsor to launch denosumab biosimilars in the US, following Sandoz’s launch of Jubbonti® and ...

On 7 July 2025, Biocon announced that it has received marketing authorisations from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for its denosumab products Evfraxy® and Vevzuo®, biosimilars to Amgen’s Prolia® and Xgeva® respectively, across all indica...

On 4 July 2025, The Bio reported that Korea’s Ministry of Food and Drug Safety has approved Celltrion’s Phase 3 clinical trial plan (IND) for CT-P44, biosimilar to Johnson & Johnson’s Darzalex® (daratumumab).  The trial will evaluate and compare the efficacy and safety ...

Over the last week, the European Commission (EC) has approved denosumab biosimilars for three sponsors:

Gedeon Richter’s Junod® and Yaxwer® (announced 1 July 2025);
mAbxience’s Izamby® and Denbrayce® (announced 2 July 2025); and
Biocon’s Evfraxy® an...