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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...

On 2 July 2025, The Economic Times reported that Aurobindo Pharma’s wholly owned subsidiary, CuraTeq Biologics, has received marketing approval from the European Commission for Dazublys®, biosimilar to Roche/Genentech’s Herceptin® (trastuzumab).  The authorisation follows t...

On 2 July 2025, Sunshine Biopharma announced that its wholly owned Canadian subsidiary, Nora Pharma, has launched Niopeg®, biosimilar to Amgen’s Neulasta® (pegfilgrastim) in Canada.  Niopeg® was approved by Health Canada in April 2024 in pre-filled syringe of 6mg/0.6 ml.

On 2 July 2025, Navlin Daily reported that the Spanish Ministry of Health issued a tender for the sustainable supply of biologics and biosimilars under a two-year Framework Agreement worth €411 million coordinated by the Instituto Nacional de Gestión Sanitaria (INGESA).

On 2 July 2025, Apotex announced that Aflivu™, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept, 2mg), has been approved by Health Canada in pre-filled syringe and vial formats.  Aflivu™ is indicated for the treatment of nAMD, macular oedema secondary to retinal vein occ...