Samsung Bioepis reported on a five-year follow-up study comparing ONTRUZANT® (trastuzumab biosimilar) with reference trastuzumab in early or locally advanced HER2 positive breast cancer. Samsung Bioepis reported that five year survival rates were 93.1% in the biosimilar tra...
A recent decision of Justice Burley in the Federal Court of Australia confirms that the bar for sufficiency and support has actually been raised by Australia’s 2012 ‘Raising the Bar...
Alvotech announced positive top-line results from its switching study between AVT02 (proposed adalimumab biosimilar) and Humira®. Alvotech reported that no significant differences were observed in clinical efficacy, safety or immunogenicity between the switching cohort and ...
BioFactura announced it has reached an agreement with Rani Therapeutics to assess BFI-751 (proposed ustekinumab biosimilar) in combination with the RaniPill® platform. The RaniPill® capsule is intended to replace subcutaneous or IV injection of biologics with oral dosing.
Samsung Bioepis announced results from a post-hoc and subgroup analysis of a Ph III clinical study of Byooviz® (ranibizumab biosimilar). Samsung Bioepis reported that the data supports biosimilarity between Byooviz® and reference ranibizumab.
Bio-Thera Solutions announced that it has entered into a commercialisation and license agreement with Sandoz to commercialise BAT1706 (proposed bevacizumab biosimilar). Under the agreement, Sandoz will commercialise the product in the US, Europe, Canada and other internatio...
The EMA approved Samsung Bioepis and Biogen’s Byooviz® (biosimilar ranibizumab) for the treatment of neovascular (wet) age-related macular degeneration, diabetic macular oedema, proliferative diabetic retinopathy, macular edema and choroidal neovascularisation.
Pearce IP is proud to announce that Pearce IP’s Founding Principal and Executive Lawyer, Patent and Trade Mark Attorney, Naomi Pearce, has once again been recognised as a World Lead...
Adaptimmune Therapeutics announced it has entered into a strategic collaboration and license agreement with Genentech to develop and commercialise allogeneic cell therapies for multiple oncology indications.
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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