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Jul 25, 2024
On 25 July 2024, Galderma announced that results from its Phase III trials on nemolizumab, published in The Lancet, demonstrate statistically and clinically significant improvements in inflammation and itch in moderate to severe atopic dermatitis. The studies...
Jul 24, 2024
On 24 July 2024, Bio-Thera Solutions announced that the FDA BLA and EMA MAA for its BAT2206 have both been accepted. BAT2206 is the first biosimilar to Janssen’s Stelara® (ustekinumab) developed by a Chinese company to be submitted to the FDA or EMA for approval. ...
Jul 24, 2024
On 24 July 2024, Merus announced that the first patient has been dosed in its Phase 3 trial evaluating the efficacy and safety of petosemtamab, compared with single agent chemotherapy or cetuximab in previously treated patients with recurrent/metastatic head and neck...
Jul 23, 2024
On 23 July 2024, the Patent Trial and Appeal Board (PTAB) issued judgment against Regeneron in relation to the inter partes review (IPR2023-00884) commenced by Samsung Bioepis, Celltrion (IPR2024-00260) and Biocon (IPR2024-00298) challenging the validity of all claims...
Jul 23, 2024
On 23 July 2024, the Medicines and Healthcare products Regulatory Agency (MHRA) approved a new indication for semaglutide (Wegovy®) to reduce the risk of serious heart problems or strokes in overweight and obese adults. Already approved for obesity and weight...
Jul 23, 2024
On 23 July 2024, Merck (known as MSD outside the US and Canada) announced positive topline results from its Phase 2b/3 trial for clesrovimab (MK-1654) in healthy infants. Clesrovimab, designed to protect infants from respiratory syncytial virus (RSV), met its primary...
Jul 22, 2024
On 22 July 2024, Samsung Bioepis announced FDA approval of Epysqli™ (SB12, eculizumab-aagh), biosimilar to Alexion’s Soliris® (eculizumab), for paroxysmal nocturnal hemoglobinuria (PNH) and atypical haemolytic uremic syndrome (aHUS). This is the second eculizumab...
Jul 22, 2024
On 22 July 2024, STADA and Alvotech announced the launch of biosimilar ustekinumab Uzpruvo® in Europe across the majority of European countries. STADA and Alvotech plan to launch Uzpruvo® in additional European countries in the coming months, following national price...
Jul 22, 2024
On 22 July 2024, Zydus Lifesciences announced that it has received approval in Mexico to market BhavaTM, biosimilar to Genentech’s Avastin® (bevacizumab) for metastatic colorectal cancer, non-squamous non-small cell lung cancer, metastatic breast cancer, glioblastoma,...
Jul 22, 2024
The US FDA is seeking information and comments to assist it in assessing how best to advance the development of new biosimilars, as part of the Biosimilar User Fee Amendments of 2022. The deadline for submitting comments is 23 October 2024. Specifically, the FDA is...
Jul 19, 2024
On 19 July 2024, Gedeon Richter announced that the European Medicines Agency (EMA) accepted its marketing authorisation applications (MAAs) for its denosumab biosimilars for all indications of Amgen's Prolia® and Xgeva® and Prolia®. Gedeon Richter’s denosumab...
Jul 18, 2024
On 18 July 2024, Boehringer Ingelheim (BI) and GoodRx announced that Boehringer's high and low concentration citrate-free Adalimumab-adbm products are being supplied in the US at a 92% discount from Humira® list price through GoodRx. This follows the news in April...
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