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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 ...

On 29 August 2024, Drug Design, Development and Therapy published the results of a Mabpharm-sponsored phase 1 study regarding CMAB015, biosimilar to Novartis’ Cosentyx® (secukinumab).  The study demonstrated that Mabpharm’s CMAB015 showed equivalent pharmacokinetics and com...

On 29 August 2024, Biocon Ltd announced that it has signed a patent settlement and licence agreement with Janssen which enables Biocon to commercialise Bmab 1200 (ustekinumab), biosimilar to Janssen’s Stelara®, in Europe, the United Kingdom, Canada and Japan. Biocon has sub...

On 26 August 2024, Regeneron filed a BPCIA complaint against Sandoz in the US District Court for the District of New Jersey, asserting infringement of 46 US patents relating to aflibercept.  The filing came two weeks after the FDA approved Sandoz’s Enzeevu™ (aflibercept-abz...