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
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
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
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®.
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
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
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
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
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)
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).
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.
On 19 February 2025, Shanghai Henlius Biotech announced that its HANBEITAI, biosimilar to Roche/Genentech’s Avastin® (bevacizumab) has received marketing approval from Bolivia’s Agencia Estatal de Medicamentos y Tecnologías en Salud (AGEMED) under the trade name Longiva™.
Australia’s Therapeutic Goods Administration (TGA) has updated its online list of prescription medicines for evaluation for the month of January. Among the applications for new medicines to be
On 18 February 2025, Celltrion announced that the European Commission has approved Eydenzelt® (CT-P42), biosimilar to Bayer/Regeneron’s Eylea® (aflibercept), for the treatment of multiple retinal
On 18 February 2025, Biocon Biologics announced that the European Commission has granted marketing authorisation for Yesintek®, biosimilar to J&J/Janssen’s Stelara® (ustekinumab). Yesintek®
On 18 February 2025, Merus announced that the FDA has granted Breakthrough Therapy Designation (BTD) to petosemtamab in combination with pembrolizumab for the first-line treatment