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In the last 2 weeks, Celltrion has received marketing approvals in the European Union and the United Kingdom for its ustekinumab, SteQeyma® (CT-P43), biosimilar to Janssen’s Stelara®.

On 26 August 2024, Celltrion announced that the European Commission has approved it...

On 3 September 2024, MSD announced that Keytruda® (pembrolizumab) plus Pfizer/Astellas antibody drug conjugate Padcev® (enfortumab vedotin-ejfv) was approved by the European Commission (EC) for the first line treatment of unresectable or metastatic urothelial carcinoma.  Th...

On 3 September 2024, Bloomberg reported that Sandoz is planning a 2026 biosimilar semaglutide launch in Canada, reportedly after Novo Nordisk’s patent protection expires.  Sandoz launches in the US and Europe are not planned until the early 2030s.

This comes after Bi...

On 2 September 2024, Shanghai Henlius Biotech announced that China’s National Medical Products Administration (NMPA) has approved an investigational new drug application (IND) for a clinical trial of HLX17, biosimilar to MSD’s Keytruda® (pembrolizumab).  Henlius reports tha...

On 1 September 2024, the PBS published its Summary of Changes, which included listing Pfizer’s Abrilada®, biosimilar to AbbVie’s Humira® (adalimumab), on the PBS in 40mg/0.8mL injections and 2 x 0.8 ml syringes.

This comes three years after Abrilada was first recomme...

On 1 September 2024, the PBS published its agenda for the September PBAC Intracycle Meeting, which will include an item providing for “initial guidance on parameters that need to be considered for future broad PBS listing proposals for PD-(L)1 inhibitors, and to advise on n...

On 30 August 2024, Korea Biomedical Review reported that UCB’s Bimzelx® (bimekizumab) has received approval from the Korean Ministry of Food and Drug Safety as a treatment for moderate to severe adult plaque psoriasis.  UCB says that Bimzelx® is the only treatment for plaqu...

On 30 August 2024, Alexion and Samsung Bioepis settled their US proceedings commenced in January 2024 regarding patents covering eculizumab.  The parties filed voluntary dismissals in proceedings in the US District Court for the District of Delaware and the Court of Appeal ...

On 30 August 2024, an article published in the American Journal of Cardiology reported the results of an analysis of data from the SELECT (Semaglutide Effects on Cardiovascular Outcomes in Patients With Overweight or Obesity) trial in relation to the effects of semaglutide ...