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On 14 July 2025, Samsung Bioepis published a whitepaper entitled “Solving the Biosimilar Void in Europe”, which proposes various recommendations for European biosimilar policy reform.

The whitepaper states that the current biosimilar policy environment in Europe need...

On 11 July 2025, Ono Pharma announced that Korea’s Ministry of Food and Drug Safety has approved an indication extension for Opdivo® (nivolumab) in combination with Yervoy® (ipilimumab) for first-line IV treatment of patients with unresectable or metastatic hepatocellular c...

On 10 July 2025, Formycon announced that it has completed patient enrolment for its clinical study, “Dahlia”, which is comparing the pharmacokinetics, safety and tolerability of FYB206 (pembrolizumab) with MSD’s Keytruda® in malignant melanoma.  The study was commenced in J...

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...