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Jun 2, 2025
On 2 June 2025, Outlook Therapeutics announced that it has launched Lytenava™ (bevacizumab gamma) in the UK and Germany, for the treatment of nAMD. Lytenava™ is the first and only…
Jun 2, 2025
On 2 June 2025, Sandoz announced its US launch of Wyost® and Jubbonti®, biosimilars to Amgen’s Xgeva® and Prolia® (denosumab), respectively. Wyost® and Jubbonti® are the first and only…
May 30, 2025
On 30 May 2025, Australia’s Therapeutic Good’s Administration (TGA) approved Celltrion’s Avtozma®, biosimilar to Roche’s Actemra® (tocilizumab), across 5 products…
May 30, 2025
On 30 May 2025, Samsung Bioepis announced that it has received marketing approval in South Korea for its second denosumab biosimilar, Xbryk™, biosimilar to Amgen’s Xgeva® (denosumab)…
May 29, 2025
On 29 May 2025, New Zealand’s Medsafe approved Sandoz’s Jubbonti® and Wyost®, biosimilars to Amgen’s Prolia® and Xgeva (denosumab), respectively. This makes Sandoz’s Jubbonti® and Wyost® the first denosumab biosimilars approved in New Zealand.
May 28, 2025
On 28 May 2025, Russia’s GxP News reported that the Russian Ministry of Health approved Russian biotechnology company Biocad’s Pertuvia™, biosimilar to Roche’s Perjeta® (pertuzumab), making it…
May 28, 2025
On 27 and 28 May 2025, Bristol Myers Squibb announced that its subcutaneous formulation of Opdivo® (nivolumab), Opdivo® SC (nivolumab co-formulated with recombinant human…
May 28, 2025
Three months after Cytiva subsidiary media supplier HyClone Laboratories filed a motion to quash a subpoena issued to it by Amgen in the context of denosumab BPCIA litigation between Amgen and Fresenius Kabi…
May 28, 2025
On 28 May 2025, Alvotech and Advanz Pharma announced that they have entered a supply and commercialisation agreement to expand their existing partnership to cover three additional biosimilar candidates…
May 27, 2025
On 27 May 2025, Formycon and Fresenius Kabi announced the Canadian launch of FYB202/Otulfi®, biosimilar to J&J/Janssen’s Stelara® (ustekinumab). The biosimilar is available in both IV and…
May 27, 2025
On 27 May 2025, Bio-Thera Solutions and Hikma Pharmaceuticals announced that the US FDA has approved BAT2206, marketed as Starjemza® (ustekinumab-hmny), biosimilar to J&J/Janssen’s…
May 27, 2025
On 27 May 2025, Sandoz’s Afqlir® and Enzeevu®, biosimilars to Regeneron/Bayer’s Eylea® (aflibercept 2mg), were approved by Australia’s Therapeutic Good’s Administration (TGA) across 4 products…
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