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On 24 June 2025, Ono Pharmaceutical and BMS announced that they have received a supplemental approval for expanded use of Ono’s Opdivo® (nivolumab) and BMS’ Yervoy® (ipilimumab) in combination for the treatment of unresectable hepatocellular carcinoma (HCC).  The approval c...

On 23 June 2025, Alvotech and Advanz Pharma announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for AVT06, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept, 2mg).

AVT06 is indicated fo...

On 4 June 2025, Regeneron and Bayer filed proceedings against Sandoz in the Australian Federal Court alleging infringement of Regeneron’s AU2012205599 relating to methods of treatment for angiogenic eye disorders.  Regeneron is seeking both an interlocutory injunction and f...

On 23 June 2025, the FDA approved Samsung Bioepis’ sBLA for an unbranded version of Hadlima® (adalimumab-bwwd), biosimilar to AbbVie’s Humira®.

Samsung Bioepis is not the first to offer an unbranded US adalimumab biosimilar, with the FDA approving Celltrion’s sBLA fo...

Several biosimilars are positioned for listing on Australia’s Pharmaceutical Benefits Scheme (PBS) from 1 July 2025, namely: Celltrion’s Steqeyma® (ustekinumab, biosimilar to Janssen’s Stelara®), Viatris’ Nepexto® (etanercept, biosimilar to Pfizer’s Enbrel®), Sandoz’s Tyruk...

On 20 June 2025, Australia’s Pharmaceutical Benefits Scheme (PBS) published its outcomes from the May 2025 PBAC intracycle meeting, with BMS’ Opdivo® (nivolumab) and Yervoy® (ipilimumab) recommended for reimbursement for stage III melanoma and Novartis’ Xolair® (omalizumab)...

On 20 June 2025, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) published the outcome of its June meeting, with positive opinions for aflibercept biosimilars of STADA, Polpharma and Advanz Pharma, and Bio-Thera’s biosimilar ustekinumab...

On 19 June 2025, Australia’s Therapeutic Goods Administration (TGA) updated its online list of prescription medicine registrations to include expanded indications for BMS’ Opdivo® (nivolumab) and Winglore™ (ipilimumab) in combination for the treatment of adult patients with...

On 19 June 2025, the Unified Patent Court (UPC) Court of Appeal issued decisions refusing two rehearing applications by Alexion Pharmaceuticals in proceedings it had brought seeking preliminary injunctions against Amgen and Samsung Bioepis in relation to the sale of their e...