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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 authorised ophthalmic formulation of bevacizumab in the EU and UK.

Lytenava™ (ONS-5010...

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 interchangeable denosumab biosimilars to be approved (in March 2024), and launched, in t...

On 30 May 2025, Australia’s Therapeutic Good’s Administration (TGA) approved Celltrion’s Avtozma®, biosimilar to Roche’s Actemra® (tocilizumab), across 5 products:

Injection concentrated vial: 80mg/4ml (444940), 200mg/10ml (444939) and 400mg/20ml (444943); and

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).  This follows the South Korean approval of Samsung Bioepis’ Obodence™ (biosimilar to Amgen...

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.

Sandoz’s Jubbonti® and...

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 the country’s first domestic biosimilar pertuzumab approved for HER2-positive bre...

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 hyaluronidase (rHuPH20)), has been approved in Europe and Canada across multiple solid tumour indicatio...