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On 21 April 2026, Celltrion announced that the intravenous (IV) formulation of Steqeyma® (ustekinumab), biosimilar to Janssen’s Stelara®, has been approved in Japan.  The newly approved formulation adds to Celltrion’s subcutaneous (SC) formulation of Steqeyma®, which was la...

On 21 April 2026, Roche announced that the FDA has accepted its supplemental Biologics License Application (sBLA) for Gazyva®/Gazyvaro® (obinutuzumab) for the treatment of systemic lupus erythematosus (SLE).  According to Roche, if Gazyva®/Gazyvaro® is approved, it will be ...

On 21 April 2026, Biocon announced that, on 3 April 2026, Health Canada approved Bosaya™ and Vevzuo™, biosimilars to Amgen’s Prolia® and Xgeva® (denosumab) respectively.  Bosaya™ is approved as a 60mg/mL PFS, while Vevzuo™ is approved as a 120 mg/1.7mL single-dose vial.  No...

On 20 April 2026, PR Newswire reported that Health Canada has approved JAMP Pharma’s Upgolyv™, biosimilar to Janssen’s Simponi® (golimumab), for the treatment of chronic inflammatory autoimmune diseases.  Upgolyv™ is the first golimumab biosimilar to be approved...

On 20 April 2026, Astellas Pharma and Pfizer announced that the FDA granted priority review of the sBLA for Astella Pharma/Pfizer’s Padcev™ (enfortumab vedotin-ejfv) in combination with MSD’s Keytruda® (pembrolizumab) or Keytruda Qlex™ (pembrolizumab and berahyaluronidase a...

On 17 April 2026, Samsung Bioepis announced new clinical data reinforcing the efficacy of its denosumab biosimilar, SB16 (Obodence®, referred to in the US as Ospomyv®), and highlighting consistent outcomes across diverse patient subgroups.  The findings were presented at th...

On 16 April 2026, the US Court of Appeals for the Federal Circuit published its decision in an appeal by Teva Pharmaceuticals in proceedings commenced in September 2018 alleging that Eli Lilly indirectly infringed Teva’s US patents 8586045, 9884907 and 9884908.  The patents...

On 15 April 2026, Mabwell announced that China’s National Medical Products Administration (NMPA) has approved the supplemental Biologics Licence Application for Maiweijian™, biosimilar to Amgen’s Xgeva® (denosumab).  The approval expands the product’s indication to in...