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Feb 24, 2025
On 24 February 2025, Johnson & Johnson (J&J) and Janssen Biotech filed a complaint in the US District Court for the District of New Jersey alleging that Samsung Bioepis has breached a settlement and licence agreement entered in July 2023 (announced in November 2023
Feb 24, 2025
On 24 February 2025, Celltrion announced that European Commission has approved Avtozma® (CT-P47), biosimilar to Roche’s RoActemra® (tocilizumab). Avtozma® is approved for all indications of
Feb 24, 2025
Following the FDA’s decision on 21 February 2025 to remove Novo Nordisk’s semaglutide products (Ozempic® and Wegovy®) from the Drug Shortages List, the regulator has been sued by the
Feb 24, 2025
BMS has announced that the FDA has accepted a supplemental biologics licence application (sBLA) for Opdivo® (nivolumab) plus Yervoy® (ipilimumab) as a potential first-line treatment option for
Feb 21, 2025
On 21 February 2025, Alvotech and Teva announced the US launch of Selarsdi® (AVT04, ustekinumab-aekn for injection), biosimilar to J&J/Janssen’s Stelara®.
Feb 21, 2025
On 21 February 2025, the FDA announced that the US semaglutide injection product shortage has resolved, such that semaglutide can now be removed from the drug shortages list. The FDA has
Feb 21, 2025
On 21 February 2025, Korean Economic Daily reported that Samsung Bioepis has succeed in a patent dispute regarding Afilivu® (SB15), biosimilar to Regeneron’s Eylea® (aflibercept). Regeneron had
Feb 20, 2025
On 20 February 2025, GSK announced that China’s National Medical Products Administration (NMPA) has accepted for review a new drug application for the use of Nucala® (mepolizumab) as
Feb 20, 2025
On 20 February 2025, CSL announced that its Andembry® (garadacimab) has been approved by Japan’s Ministry of Health, Labour and Welfare (MHLW) in subcutaneous 200mg injection pens for
Feb 20, 2025
On 20 February 2025, Genmab announced that Japan’s Ministry of Health, Labour and Welfare has approved Epkinly® (epcoritamab) for the treatment of patients with relapsed or refractory (R/R)
Feb 20, 2025
On 20 February 2025, Bayer announced that Health Canada has approved Eylea® HD (aflibercept injection, 8mg) in a pre-filled syringe with integrated OcuClick™ dosing system for the treatment of nAMD and diabetic macular oedema (DME).
Feb 19, 2025
On 19 February 2025, Celltrion announced that the European Commission has approved Stoboclo® and Osenvelt® (CT-P41), biosimilars to Amgen’s Prolia® and Xgeva® (denosumab), respectively, for the same indications as the reference medicines.
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