Mylan and Biocon have said that the 48-week results of Ogivri from the Heritage study 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 US, 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.
 
“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,” stated Arnd Annweiler, head of global biologics, R&D, Mylan .
 
According to Dr Narendra Chirmule, sr. vice president & head, R&D, Biocon, 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.”
 
In addition, data related to Mylan and Biocon’s proposed biosimilar to Neulasta (pegfilgrastim) were selected for publication in conjunction with the 2018 ASCO Annual meeting.