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On 16 July 2025, the US District Court for the District of New Jersey made consent orders reflecting a settlement of the patent infringement litigation brought by Amgen against Accord and Intas relating to Accord/Intas’ biosimilar denosumab.  While the terms of the settleme...

On 15 July 2025, Biocon Biologics announced that the FDA has approved Kirsty™ (insulin aspart-xjhz) as the first and only interchangeable biosimilar to Novo Nordisk’s NovoLog®.

Kirsty™ (100 units/mL) will be available as a single-patient-use prefilled pen for subcuta...

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...