On 24 December 2024, GlycoNex announced that it has entered into a licensing agreement with an undisclosed partner for SPD8 (denosumab), biosimilar to Amgen’s Prolia® and Xgeva®. Under the agreement, the licensee will be responsible for developing SPD8, securing regulatory approval, and commercialising the biosimilar in an undisclosed market.
On 23 December 2024, following the November 2024 recommendation by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP), the European Commission has approved Opdivo® (nivolumab) plus Yervoy® (ipilimumab)
On 23 December 2024, Celltrion announced that Korea’s Ministry of Food and Drug Safety has approved its Aptozma™/CT-P47, biosimilar to Roche’s Actemra® (tocilizumab), for all indications of
On 21 December 2024, Novo Nordisk announced that FDA has approved its Alhemo® (concizumab) injection as a once-daily prophylactic treatment to prevent or reduce the frequency of bleeding
On 21 December 2024, CuraTeQ Biologics announced that it has received marketing authorisation from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for Bevqolva™,
On 20 December 2024, Australia’s Pharmaceutical Benefits Assessment Committee (PBAC) published the outcomes considered at its November 2024 meeting, recommending listing for one biosimilar,
On 20 December 2024, the UPC Court of Appeal denied Alexion preliminary injunctions against Samsung Bioepis and Amgen in relation to the sale of biosimilars to Alexion’s Soliris® (eculizumab) in the EU. Alexion had originally filed the proceedings in the UPC against Samsung Bioepis and Amgen in March 2024, seeking preliminary injunctions for alleged infringement of EP 3 167 888 (method of treating paroxysmal nocturnal hemoglobinuria).
On 20 December 2024, Fresenius Kabi announced that it had entered into a licensing agreement with SamChunDang Pharm (SCD) to exclusively commercialise
On 19 December 2024, New Zealand’s Pharmac issued a media release requesting feedback on proposals to fund six medicines for cancer and antibiotic resistant infections from 1 April 2025, which includes:
On 18 December 2024, Australia’s Pharmaceutical Benefits Scheme (PBS) published its agenda for the May 2025 Pharmaceutical Benefits Advisory Committee (PBAC) meeting.
On 17 December 2024, Gilead Sciences announced that the US FDA has granted Breakthrough Therapy Designation (BTD) to Trodelvy® (sacituzumab govitecan-hziy) for the treatment of adult
On 17 December 2024, Eli Lilly announced that China’s National Medical Products Administration (NMPA) has approved its donanemab-azbt Kisunla® (350 mg/20 mL every four weeks injection for IV infusion)
On 16 December 2024, Johnson & Johnson (J&J) announced that it submitted a supplemental Biologics Licence Application (sBLA) to the US FDA seeking the approval of Simponi® (golimumab) for
On 16 December 2024, GSK announced that the US FDA has granted Breakthrough Therapy Designation to Jemperli® (dostarlimab) for the treatment of patients with locally advanced mismatch
On 16 December 2024, Johnson & Johnson (J&J) announced that the US FDA issued a Complete Response Letter (CRL) for its US Biologics License Application (BLA) for a fixed subcutaneous…
On 15 December 2024, Biocon announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) had issued a positive opinion recommending approval of