On 19 August 2026, Ono announced that it has received additional approval for Opdivo® (nivolumab) Intravenous Infusion from the Taiwan Food and Drug Administration (TFDA), for the neoadjuvant treatment of adult patients with resectable Non-Small Cell Lung Cancer (NSCLC) and...
Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®. Significant biosimilar activities for the week ending 14 August 2026 are set out belo...
On 18 August 2026, Biocon announced that it has received supplemental FDA approval for Yesintek®, biosimilar to Janssen’s Stelara® (ustekinumab), in a single-dose prefilled autoinjector format (45 mg/0.5 ml and 90 mg/ml).
On 18 August 2026, Avalon Pharmaceutical and Bio-Thera Solutions announced that they have entered into an exclusive licensing agreement for the commercialisation of Bio-Thera’s BAT2406, biosimilar to Sanofi/Regeneron’s Dupixent® (dupilumab), in MENA.
On 18 August 2026, Korea Biomedical Review reported that Sam Chun Dang (SCD) signed a settlement agreement with Regeneron and Bayer to resolve all patent disputes in Europe, Korea and Japan involving SCD411, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept) 2 mg. ...
On 17 August 2026, Sandoz and Shanghai Henlius Biotech announced that they have entered into a major development, manufacturing and commercialisation collaboration agreement, covering up to 10 biosimilars (including monoclonal antibodies and/or antibody-drug conjugates).
On 13 August 2026, Celltrion announced that the FDA has granted fast track designation to CT-P73, an antibody drug conjugate (ADC) for the treatment of patients with recurrent and metastatic cervical cancer who have previously received platinum based chemotherapy.
On 13 August 2026, Bayer announced that China’s National Medical Products Administration (NMPA) has accepted for review its application for Eylea® (aflibercept) 8 mg (114.3 mg/ml solution) for injection) for the treatment of macular oedma following retinal vein occlusion (R...
All of Pearce IP’s New Zealand Executives have been recognised in the 2026 Doyle’s Guide – Leading Intellectual Property Lawyers (New Zealand) rankings.
Paul Johns is one of 1...
Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®. Significant biosimilar activities for the week ending 7 August 2026 are set out below...
Pearce IP publishes free e-books addressing various aspects of patent law and practice in Australia, with a focus on issues affecting pharmaceutical, biopharmaceutical and other life sciences companies.
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