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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...

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 (subsequently settled), HyClone has filed a similar motion to quas...

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 in Europe.  The products covered by the agreement are biosimilars to Nov...

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 subcutaneous injection presentations to treat adults with moderately to severely ...