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Dec 26, 2024
On 26 December 2024, Hikma Pharmaceuticals announced that it has received FDA approval for, and launched, its generic version of Novo Nordisk’s Victoza® (liraglutide) in the US in a 6mg/mL dosage form.
Dec 24, 2024
On 24 December 2024, Bio-Thera Solutions announced that it has entered an exclusive licensing agreement with Tabuk Pharmaceutical Manufacturing Company in relation to the commercialisation of BAT2206 (ustekinumab), biosimilar to J&J/Janssen’s Stelara®.
Dec 24, 2024
On 24 December 2024, Biocon announced that the company and its European partner, Zentiva, have received Decentralised Procedure (DCP) approval for liraglutide in the European Union. The approval is for the generic versions of Novo Nordisk’s Victoza®, to treat type-2 diabetes, and Saxenda®, used in the treatment of weight management.
Dec 24, 2024
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.
Dec 23, 2024
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)
Dec 23, 2024
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
Dec 21, 2024
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
Dec 21, 2024
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™,
Dec 20, 2024
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,
Dec 20, 2024
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).
Dec 20, 2024
On 20 December 2024, Fresenius Kabi announced that it had entered into a licensing agreement with SamChunDang Pharm (SCD) to exclusively commercialise
Dec 19, 2024
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:
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