The first FDA-approved biosimilar trastuzumab based on the totality of evidence and the first with OS data at 36 months1,2,12

  • Confirmed biosimilarity based upon the totality of evidence
  • Demonstrated equivalence when compared to reference trastuzumab in efficacy and safety in the phase 3 HERITAGE trial of patients with HER2+ metastatic breast cancer2,10
    • Equivalent ORR at 24 weeks
    • The first FDA-Approved biosimilar with similar PFS and OS at 36 months compared to reference trastuzumab
      • OGIVRI® mOS=35.0 months vs. trastuzumab mOS=30.2 months (HR=0.90 [95% CI: 0.69–1.17]; log-rank p=0.427)
    • Similar safety with no new safety signals observed in long-term follow-up10,12
  • Offers similar patient access support service to provide a seamless transition to OGIVRI
  • Available in single (150 mg) and multi-dose (420 mg) vials
  • Delivers on the promise of providing greater access to patients
 

Patients in >40 countries have been treated with formulations of Biocon Biologics biosimilar trastuzumab

 

Biocon Biologics is committed to deliver patient access to one of the World Health Organization's list of essential medicines

OGIVRI indicated for

  • Adjuvant Breast Cancer
  • Metastatic Breast Cancer
  • Metastatic Gastric Cancer

Important Safety Information

  • OGIVRI administration can result in serious and fatal infusion reactions and pulmonary toxicity
  • OGIVRI administration can result in sub-clinical and clinical cardiac failure
  • Discontinue OGIVRI for anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome