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On 24 January 2024 New Zealand introduced a new IP Bill for Geographical Indications (GIs).
The bill will amend NZ law to implement aspects of the Free Trade Agreement with the European Union signed in Brussels on 9 July 2023 by providing for the registration of Europ...

AstraZeneca and Daiichi Sankyo announced that the FDA has accepted its supplemental Biologics License Application (sBLA) for Enhertu® (trastuzumab deruxtecan) and has granted Priority Review to treat patients with unresectable or metastatic HER2-positive (immunohistochemist...

Alvotech announced positive top-line results for AVT03, its biosimilar to Amgen Inc’s Prolia® and Xgeva® (denosumab).  The study (AVT03-GL-P01) was a randomised, double-blind, parallel-group study evaluating the pharmacokinetics, safety, and tolerability of AVT03 compared t...

Astellas announced that on 26 January the European Medicines Agency (EMA) validated for review a Type II variation application for PADCEVTM (enfortumab vedotin) with KEYTRUDA® (pembrolizumab) as a combination therapy for the first-line treatment of adult patients with previ...

Celltrion announced that it has submitted a Biologics License Application (BLA) for CT-P47, biosimilar to Genentech’s Actemra® (tocilizumab), to the FDA.  Celltrion is seeking approval for CT-P47 in both intravenous and subcutaneous formulations. Biogen received FDA approva...

AbbVie announced it will invest US$233M in its biologics manufacturing facility in Singapore.  The investment will add 24,000L of biologics drug-substance capacity to AbbVie’s manufacturing network.  The expansion intends to support current products and emerging immunology ...

A study published in Inflammatory Bowel Diseases on 25 January 2024 concluded that 130 US patients with inflammatory bowel disease who switched from Janssen’s Remicade® (infliximab) to two different biosimilars were not associated with flares compared to patients who receiv...

Regeneron and Sanofi announced that the FDA has approved Dupixent® (dupilumab) to treat paediatric patients aged 1 to 11 years (weighing at least 15 kg) with eosinophilic esophagitis (EoE).  Dupixent® is the first and only medicine approved in the US to treat these patients...

Samsung Biologics revealed in its Q4 2024 Earnings that its subsidiary Samsung Bioepis surpassed ₩1T (1 trillion Korean won) annual revenue in 2023 for the first time in the company’s history.  This was due to the 8% growth in revenue from new product launches and sales exp...