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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.  

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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 squamo...

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 of Re...

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 management, s...

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 endpo...

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 bio...

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 appro...

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, renal...

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 ...