Alvotech announced positive top-line results for AVT03, its biosimilar to Amgen Inc’s Prolia® and Xgeva®...
EMA Validates Type II Variation for Padcev® (enfortumab vedotin) with Merck’s Keytruda® in for First-Line Treatment of Advanced Bladder Cancer
Astellas announced that on 26 January the European Medicines Agency (EMA) validated for review a Type II variation...
Celltrion Submits BLA for CT-P47, Biosimilar to Genentech’s Actemra® (tocilizumab)
Celltrion announced that it has submitted a Biologics License Application (BLA) for CT-P47, biosimilar to Genentech’s...
AbbVie to Expand Biologics Manufacturing Facility in Singapore with US$223M Investment
AbbVie announced it will invest US$233M in its biologics manufacturing facility in Singapore. The investment will add...
Study Demonstrates Double Switching From Janssen’s Remicade® (infliximab) to Biosimilars Not Associated with Flares
A study published in Inflammatory Bowel Diseases on 25 January 2024 concluded that 130 US patients with inflammatory...
New Indication Alert: Regeneron/Sanofi’s Dupixent® (dupilumab) FDA-Approved to Treat EoE in Children One Year and Older
Regeneron and Sanofi announced that the FDA has approved Dupixent® (dupilumab) to treat paediatric patients aged 1 to...
Samsung Bioepis Surpasses ₩1T Revenue in 2023
Samsung Biologics revealed in its Q4 2024 Earnings that its subsidiary Samsung Bioepis surpassed ₩1T (1 trillion...
Study Shows That First Line Treatment of Pemphigus Using Rituximab May Be Effective
A study published in JAMA Dermatol shows that rituximab had positive short-term efficacy and safety when compared to a...
Approval Alert: Samsung Bioepis’ Onbevzi® (bevacizumab) Approved by TGA
The Therapeutic Goods Administration (TGA) has approved Samsung Bioepis’ Onbevzi® (SB8), biosimilar to Genentech’s...
Bayer’s high dose Eylea® (8mg aflibercept) Accepted by NMPA
Marketscreener reported that Bayer’s application for regulatory approval of Eylea® 8mg (aflibercept) to treat...
WuXi XDC and Celltrion Ink MOU to Develop and Manufacture ADCs
WuXi XDC and Celltrion announced that they have signed a memorandum of understanding (MOU) for development and...
Outlook Receives FDA Agreement under SPA for Ophthalmic Bevacizumab Formulation Trial
Outlook Therapeutics announced it received an agreement from the FDA under a Special Protocol Assessment (SPA) for its...
Phase III of the Checkmate 722 BMS Clinical Trial Shows No Significant Improvement on PFS With Addition of Opdivo® (nivolumab)
A Bristol Myers Squibb (BMS) study published in the Journal of Clinical Oncology concluded that Opdivo® (nivolumab)...
Sandoz to Acquire Coherus’ Cimerli® Ranibizumab Biosimilar for US$170M
Sandoz announced that it has signed an agreement to acquire Coherus Biosciences’ Cimerli®, biosimilar to Genentech’s...
Approval Alert: Samsung Bioepis’ Episcli® (SB12) (eculizumab) Approved in Korea
PulseNews reported that Samsung Bioepis has received approval for Episcli® (SB12), biosimilar to Alexion’s Soliris®...
First Biosimilar Approval Alert: Amgen’s Wezlana® (ustekinumab) Approved by TGA
The Therapeutic Goods Administration (TGA) has approved Amgen’s Wezlana®, the first approved biosimilar to Janssen’s...