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On 5 August 2025, Actor Pharmaceuticals filed legal proceedings against Regeneron and Bayer in the Australian Federal Court.  While the details of the proceedings have not yet been published, it is expected that the proceedings are likely to relate to one or more Australian...

On 5 August 2025, Polpharma Biologics and Fresenius Kabi announced that they have entered into a global licensing agreement (excluding Middle East & North Africa) for the commercialisation of PB016, biosimilar to Takeda’s Entyvio® (vedolizumab).  PB016 was developed by ...

On 5 August 2025,  CivicaScript, LLC announced that it will distribute Fresenius Kabi’s unbranded ustekinumab-aauz, biosimilar to J&J/Janssen’s Stelara®, in the US from 1 January 2026.  CivicaScript is a nonprofit company dedicated to bringing low-cost generic medicines...

On 5 August 2025, Kashiv BioSciences and MS Pharma announced that they entered into a licence and supply agreement for Kashiv’s ADL-018, biosimilar to Novartis’ Xolair® (omalizumab), for the Middle East and North Africa (MENA).

Under the terms of the agreement, Kashi...

On 4 August 2025, Australia’s Therapeutic Goods Administration (TGA) approved Celltrion’s Omlyclo®, biosimilar to Genentech/Novartis’ Xolair® (omalizumab), in two pre-filled pen (PFP) presentations (75.mg/0.5ml and 150mg/ml).

Celltrion’s Omlyclo® is currently the onl...

On 14 July 2025, Fresenius Kabi filed petitions for IPR (inter partes review) against Regeneron’s US Patent No. 11,084,865 to ophthalmic formulations of aflibercept and US Patent No. 10,828,345 to methods of treating angiogenic eye disorders.  Fresenius is seeking to overtu...

On 4 August 2025, Celltrion announced that, according to market research firm IQVIA, Yuflyma®, biosimilar to AbbVie’s Humira® (adalimumab), reached 24% market share in Europe in Q1 2025, up 3% on the previous quarter and now only one percentage point behind the leading prod...

As reported by Medical Dialogues, India’s Central Drugs Control Organisation (CDSCO) has reviewed and accepted without objection a final Clinical Study Report (CSR) submitted by Intas Pharmaceuticals Ltd. for its proposed denosumab biosimilar.  In the CSR, data was presente...

On 1 August 2025, the Pharmaceutical Benefits Scheme (PBS) published its Summary of Changes, which includes the following:

Sandoz’s Wyost® and Jubbonti®, the first biosimilars to Amgen’s Prolia® and Xgeva® (denosumab) to be PBS listed;
Celltrion’s Steqeyma®...

On 1 August 2025, the Korea Biomedical Review reported that Boryung launched Samsung Bioepis’ denosumab biosimilar (Xbryk™) in the Korean market, following its regulatory approval in May 2025.  Xbryk™ is a biosimilar to Amgen’s Xgeva® and is approved to prevent skeletal com...