Sandoz announced that it launched biosimilar natalizumab (Tyruko®) in Germany on 31 January 2024 for the treatment of...
Biogen Redirects Resources from Aduhelm® (aducanumab) to Advance Leqembi® (lecanemab)
Biogen announced it will reprioritise resources allocated to Aduhelm® (aducanumab) to advance Leqembi® (lecanemab) to...
Astellas Submits sNDA for Padcev® (enfortumab vedotin) with Merck’s Keytruda® in Japan
Astellas announced it submitted a Supplemental New Drug Application (sNDA) to the Japanese Ministry of Health, Labour...
Study Finds No Difference in Disease Activity when Comparing GP2015/SB4 (etanercept biosimilars) and GP2017 (adalimumab biosimilar) to their Originator Drugs
A study by the Italian University of Bologna published in Springer Link's Clinical Drug Investigation, found that...
J&J Submits sBLA to FDA for Darzalex Faspro® (daratumumab and hyaluronidase-fihj) Combination
Johnson & Johnson announced it submitted a supplemental Biologics License Application (sBLA) to the FDA seeking...
FDA Grants Priority Review of AZ/Daiichi Sankyo’s Enhertu®
AstraZeneca and Daiichi Sankyo announced that the FDA has accepted its supplemental Biologics License Application...
Alvotech Reports Positive Top-line Results from Study on AVT03, Biosimilar to Amgen Inc’s Prolia® and Xgeva® (denosumab)
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...