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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.

Imuldosa® (previously known as DMB-3115) was developed jointly by Dong-A So...

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 Supplementary Protection Certificates (SPC) by manufacturing and stockpiling...

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:

for adult and paediatric patients (12 years and older) with unresectable or metastatic micr...

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 the treatment of macular oedema following retinal vein occlusion (RVO).

Eyl...

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®.

T...

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 bortezomib, lenalidomide and dexamethasone for adult patients with newly dia...

On 6 April 2025, ChosunBiz reported that Samsung Bioepis has received approval in South Korea for Obodence™, biosimilar to Amgen’s Prolia® (denosumab).

Obodence™ is Samsung Bioepis’ 10th biosimilar to be approved in South Korea, including following Epyztek® (ustekinu...

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 due to: macular oedema secondary to retinal vein occlusion (RVO), diabetic macular oedema (DM...