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Apr 14, 2025
On 14 April, Celltrion announced that it has secured interchangeability designation in the US for its high concentration (100mg/mL) citrate free adalimumab biosimilar, Yuflyma® (adalimumab-aaty)…
Apr 10, 2025
On 10 April 2025, Aurobindo subsidiary, CuraTeQ Biologics, reported its successful Phase I results for BP16, biosimilar to Amgen’s Prolia® (denosumab)…
Apr 10, 2025
On 10 April 2025, Biocon Biologics announced that the FDA has approved its Jobevne™ (bevacizumab-nwgd), biosimilar to Roche/Genentech’s Avastin® (bevacizumab)
Apr 8, 2025
On 8 April 2025, The Bio reported that Dong-A ST has launched Imuldosa®, biosimilar to J&J’s Stelara® (ustekinumab) in the UK and Ireland, following its launch in Germany in January 2025…
Apr 8, 2025
Samsung Bioepis has successfully defeated Janssen Biotech’s appeal in the Hague Court of Appeal in which Janssen sought to overturn an earlier ruling that Samsung Bioepis did not infringe Janssen’s…
Apr 8, 2025
On 8 and 11 April 2025, respectively, BMS announced that the FDA has approved Opdivo® (nivolumab) plus Yervoy® (ipilimumab) as a first-line treatment in two new indications…
Apr 8, 2025
On 8 April 2025, Bayer announced that it has filed an application with the European Medicines Agency (EMA) for approval of Eylea™ 8mg (aflibercept 8mg, 114.3 mg/ml solution for injection) for…
Apr 7, 2025
On 7 April 2025, Teva and Samsung Bioepis announced the US launch of Epysqli® (eculizumab-aagh), biosimilar to Alexion’s Soliris®. According to the joint announcement, Epysqli® will be offered at a 30% discount of the Wholesale Acquisition Cost (WAC) of Soliris®…
Apr 7, 2025
On 7 April 2025, Johnson & Johnson (J&J) announced that the European Commission has approved an indication extension for Darzalex® (daratumumab) subcutaneous formulation in combination with…
Apr 6, 2025
On 6 April 2025, ChosunBiz reported that Samsung Bioepis has received approval in South Korea for Obodence™, biosimilar to Amgen’s Prolia® (denosumab)…
Apr 4, 2025
On 4 April 2025, the European Commission granted marketing authorisation to Amgen’s Pavblu®(aflibercept 2mg), biosimilar to Bayer/Regeneron’s Eylea® for nAMD and visual impairment…
Apr 4, 2025
On 4 April 2025, Sandoz’s Tyruko®, biosimilar to Biogen’s Tysabri® (natalizumab), was approved by Australia’s Therapeutic Goods Administration (TGA). This is the first biosimilar natalizumab…
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