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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...

A study published in JAMA Dermatol shows that rituximab had positive short-term efficacy and safety when compared to a standard corticosteroid regimen for patients with pemphigus.  

The Therapeutic Goods Administration (TGA) has approved Samsung Bioepis’ Onbevzi® (SB8), biosimilar to Genentech’s Avastin® (bevacizumab).  It is indicated to treat colorectal cancer, breast cancer, non-squamous small cell lung cancer (NSCLC), renal cell cancer, glioma, epi...

Marketscreener reported that Bayer’s application for regulatory approval of Eylea® 8mg (aflibercept) to treat neovascular (wet) age-related macular degeneration (nAMD) has been accepted by the Chinese National Medical Products Administration (NMPA) for review.
On 19 J...