Bengaluru :  – Mylan N.V.  and Biocon Ltd.   announced that 48-week results from the HERITAGE study will be presented at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, June 1-5. The HERITAGE study compared Ogivri™, the first biosimilar for Herceptin® approved in the U.S., to the reference product in patients with metastatic breast cancer in combination with taxanes for the first 24 weeks and then as a monotherapy until progression. Data obtained after 48 weeks of treatment will be included as part of the Clinical Science Symposium titled, “The Arrival of Biosimilars,” on June 4.

Mylan’s Head of Global Biologics, R&D, Arnd Annweiler, commented: “We continue to be pleased with the progress of the HERITAGE study, which helped to support the recent FDA approval of Ogivri, the first biosimilar for Herceptin in the U.S. The 48-week data further demonstrate that Ogivri is highly similar to Herceptin and no clinically meaningful differences exist between the biosimilar product and Herceptin in terms of safety, purity and potency. We applaud ASCO for continuing to support biosimilar development and recognizing the need for more affordable treatment options for cancer patients.”

Dr Narendra Chirmule, Sr. Vice President & Head of R&D at Biocon, said: “We are extremely pleased to present the 48-week additional data from the HERITAGE study at ASCO, which further demonstrate that our biosimilar trastuzumab, Ogivri, does not have any clinically meaningful differences in terms of safety, purity and potency in comparison to the reference product, Herceptin. We believe this positive data will enable wider adoption of our biosimilar trastuzumab, thus expanding access to this therapy for HER2-positive metastatic breast and gastric cancer patients across the world.”