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On 22 October 2024, Samsung Biologics announced that it has entered a contract manufacturing deal worth USD 1.24 billion, with an un-named Asia-based pharmaceutical company.  The contract extends until December 2037, with production to occur at Samsung Biologics’ biomanufac...

On 22 October 2024, the United States Court of Appeals for the Federal Circuit ruled that Regeneron was not entitled to an injunction preventing Amgen from launching its aflibercept biosimilar pending appeal.  That appeal concerns a September 2024 decision of the US Distric...

On 22 October 2024, the US Food and Drug Administration (FDA) posted notices detailing Novo Nordisk’s request to include semaglutide in the FDA’s Demonstrable Difficulties for Compounding (DDC) list.  The request aims to prevent compounding pharmacies from producing copied ...

On 22 October 2024, Alvotech and Teva announced US FDA approval of an additional presentation of Selarsdi™ (ustekinumab), biosimilar to Janssen’s Stelara®.  The additional presentation covers Selarsdi™ 130 mg/26 ml in a single-dose vial for intravenous infusion and ex...

In August 2024, Xbrane commenced its out-licensing process for Xdivane™, biosimilar to BMS’ Opdivo® (nivolumab), and XB003 (previously known as Xcimzane™, BIIB801), biosimilar to UCB’s Cimzia® (certolizumab pegol).

On 21 October 2024, Xbrane announced it reached agre...

On 21 October 2024, Novo Nordisk announced positive results from the SOUL cardiovascular outcomes trial, which evaluated the impact of Rybelsus® (oral semaglutide) on major adverse cardiovascular events (MACE) in individuals with type 2 diabetes and established cardiovascul...

On 21 October 2024, the Australian TGA approved three presentations of Samsung Bioepis’ Epyztek®, biosimilar to Janssen’s Stelara® (ustekinumab): 90 mg/1 mL solution for injection pre-filled syringe, 45 mg/0.5 mL solution for injection pre-filled syringe and 5 mg/1 mL solut...

On 18 October 2024, Regeneron announced positive three year results for Eylea HD® (aflibercept, 8 mg injection) from an extension study of the Phase 3 PHOTON trial in patients with diabetic macular oedema (DME).  The results were presented at the American Academy of Ophthal...

On 18 October 2024, Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) published the outcomes of its September 2024 intracycle meeting.  This included consideration of proposals for broad Pharmaceutical Benefits Scheme (PBS) listings for PD-(L)1 inhibitors, inclu...