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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 ...

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 biosimil...

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 Ap...

On 18 July 2024, Roche announced that FDA has accepted its supplemental BLA for Susvimo®, a refillable ocular implant containing a specialised formulation of ranibizumab, for the treatment of diabetic macular oedema (DME) and diabetic retinopathy (DR).

This follows t...