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Daiichi Sankyo & Astrazeneca
NEWS

Daiichi Sankyo & AstraZeneca Report Topline P-III (DESTINY-Breast09) Trial Data of Enhertu for HER2+ Metastatic Breast Cancer

Shots: Daiichi Sankyo & AstraZeneca have reported topline P-III (DESTINY-Breast09) trial data on Enhertu (5.4mg/kg) ± pertuzumab vs taxane, trastuzumab & pertuzumab (THP) as a 1L treatment of HER2+ metastatic breast cancer pts (n=1157) Enhertu + pertuzumab showed improved PFS (1EP), with PFS benefit observed across all pre-specified subgroups during interim analysis; OS (2EP) remain immature…
April 21, 2025

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Daiichi Sankyo
NEWS

Daiichi Sankyo Reports the First Patient Dosing in P-III (DESTINY-Gastric05) Trial of Enhertu Regimen to Treat G/GEJ Cancer

Shots: Daiichi has reported first pts dosing in its P-III (DESTINY-Gastric05) trial assessing Enhertu regimen in 1L, inoperable, locally advanced or metastatic HER2+ (IHC 3+ or IHC 2+/ISH+) G/GEJ cancer pts, with PD-L1 CPS ≥1 Trial will assess efficacy & safety of Enhertu (5.4mg/kg) + Keytruda + fluoropyrimidine-based CT vs trastuzumab + Keytruda + Pt-based…
April 2, 2025

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Accord Healthcare
NEWS

Accord BioPharma’s Hercessi 420mg (Biosimilar, Herceptin) Receives the US FDA’s Approval to Treat Various HER2-Overexpressing Cancer 

Shots:  The US FDA has granted approval to the company’s Hercessi (420mg), a biosimilar version of Herceptin (trastuzumab), for the treatment of HER2-overexpressing breast & G/GEJ adenocarcinoma. It is planned to be introduced in early 2025  The approval was supported by the analytical, preclinical & clinical data showing similarity b/w Hercessi & Herceptin from the…
September 18, 2024

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NEWS

Accord BioPharma’s Hercessi 420mg (Biosimilar, Herceptin) Receives the US FDA’s Approval to Treat Various HER2-Overexpressing Cancer 

  Shots:  The US FDA has granted approval to the company’s Hercessi (420mg), a biosimilar version of Herceptin (trastuzumab), for the treatment of HER2-overexpressing breast & G/GEJ adenocarcinoma. It is planned to be introduced in early 2025  The approval was supported by the analytical, preclinical & clinical data showing similarity b/w Hercessi & Herceptin from…
September 18, 2024

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NEWS

Accord BioPharma’s Hercessi (Biosimilar, Herceptin) Receives the US FDA Approval

Shots:  Accord BioPharma's Hercessi (trastuzumab-strf; 150mg; IV), a biosimilar to Herceptin (trastuzumab), has been approved by the US FDA to treat HER2 overexpressing breast and G/GEJ cancer in the US  The approval was based on 2 studies incl. P-I (HLX02-HV01 & HLX02-HV02) trial assessing the single-dose, PK equivalence in healthy volunteers. P-III (HLX02-BC01) trial assessing…
April 29, 2024

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NEWS

Biocon Biologics Enters into a Collaboration Agreement with Sandoz for the Commercialization of Ogivri (biosimilar, trastuzumab) and Abevmy (biosimilar, bevacizumab) to Treat Cancer 

Shots:   Under the terms of the agreement, Sandoz received the exclusive right to commercialize and distribute Ogivri, the biosimilar version of Herceptin & Abevmy, the biosimilar version of Avastin, across Australia for the treatment of various cancer indications   Additionally, Sandoz AG will be held responsible to distribute Biocon’s biosimilar versions of trastuzumab and bevacizumab across Australia…
February 9, 2024

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Insights+ Key Biosimilars Events of May 2020
INSIGHTS+

Insights+ Key Biosimilars Events of May 2020

Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency Fresenius Kabi expanded its footprints with the acceptance of MAA and BLA of its MSB11455 (biosimilar, pegfilgrastim) in the EU and the US respectively, and also signed an agreement with Medec to commercialize Idacio (adalimumab, biosimilar) in…
June 5, 2020

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