Ogivri is the first biosimilar for Herceptin approved by the US Food and Drug Administration (FDA) for all indications including HER2 -positive breast and gastric cancers
Mylan and Biocon recently announced that the final data from the HERITAGE study will be presented at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago. The HERITAGE study compared Ogivri to the reference product, Herceptin, in patients with HER2+ metastatic breast cancer in combination with taxanes for the first 24 weeks and then as a monotherapy until progression. Safety and overall survival, cumulative through 36 months of follow-up, will be presented as part of the Breast Cancer – Metastatic session, “HER2-Positive Disease: How Far Have We Come?,” on 2nd June.
Christiane Hamacher, CEO, Biocon Biologics, said “The final safety and overall survival data from the HERITAGE study for our biosimilar trastuzumab, Ogivri, cumulative through 36 months of follow up, reconfirms that efficacy and safety is very similar to the reference product, Herceptin. The presentation of this data at ASCO will enable a wider adoption of our biosimilar trastuzumab which has so far benefited thousands of patients across the globe. Biocon Biologics is committed to enable access to this high quality affordable therapy for HER2-positive breast and gastric cancer patients as we strive to co-create a healthy future.”
Mylan Head of Global Biologics, R&D, Arnd Annweiler, commented, “We’re pleased with the final results of the landmark HERITAGE study which further validate the safety and efficacy profile of Ogivri, and confirm that no clinically meaningful differences exist between the biosimilar product and Herceptin in terms of safety, purity and potency. We have long been committed to the science and clinical data behind this important treatment and are proud to reach this milestone. Today, we continue on our mission to increase access to Ogivri and the additional biosimilars in our pipeline for patients around the world. We’re grateful for ASCO’s recognition of this critical study over the past years and the important role they have played in educating and instilling confidence in healthcare providers and patients about the safety, efficacy and value of biosimilars.”
Mylan and Biocon’s biosimilar for Herceptin has received regulatory approval in more than 65 countries worldwide.