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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...

In what is said to be the largest long-term extension dataset to date for diabetic macular oedema (DME), Roche reports that its Vabysmo® (faricimab) was well-tolerated in DME patients receiving treatment for up to 4 years.  The “RHONE-X” study met all primary endpoints, wit...

AVEO Oncology has revealed that its Phase 3 clinical trial (TiNivo-2) results demonstrate the addition of Opdivo® (nivolumab) to low dose Fotivda® (tivozanib) after prior immune checkpoint inhibitor (ICI) treatment is not superior to standard dose tivozanib alone, with the ...

On 17 July 2024, Boan Biotech announced that China’s Centre for Drug Evaluation of the National Medical Products Administration (NMPA) has accepted its BLA for BA9101, biosimilar to Regeneron’s Eylea® (aflibercept).  The BA9101 application is for all Eylea® indications, nam...

On 17 July 2024, Junshi Biosciences announced that China’s National Medical Products Administration has accepted for review its supplemental new drug application (sNDA) for Tuoyi® (toripalimab) combined with bevacizumab for first-line treatment of unresectable or metastatic...