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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...
Jul 18, 2024
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...
Jul 18, 2024
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...
Jul 18, 2024
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,...
Jul 17, 2024
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®...
Jul 17, 2024
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...
Jul 17, 2024
On 17 July 2024, Celltrion reported that its Remsima SC (infliximab subcutaneous injection), biobetter to Remsima® (IV product), a biosimilar to Janssen’s Remicade® (infliximab), has recorded European market share of over 20% for the first time since its 2020 EU...
Jul 17, 2024
On 17 July 2024, ASLAN Pharmaceuticals announced that it has filed for voluntary liquidation of its Singaporean sole operating subsidiary and will itself also apply for liquidation. ASLAN reports that the appointed liquidator of the Singapore subsidiary will seek...
Jul 16, 2024
On 16 July 2024, the Munich Central Division of the UPC issued judgment in revocation actions brought by Sanofi and Regeneron, declaring Amgen’s evolocumab patent EP3666797 invalid in all 17 UPC contracting States, based on lack of inventive step. This is the first...
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