Mylan, Biocon launch biosimilar of cancer drug Herceptin in US
It is a biosimilar of global pharma major Roche's Herceptin.
Ogivri is available in a 420 mg multi-dose vial and a 150 mg single-dose vial in order to provide the patients dosing and treatment flexibility, the companies said in a joint statement.
"The US launch of Ogivri, the biosimilar trastuzumab co-developed by Biocon Biologics and Mylan, marks a significant milestone in our biosimilars journey," Biocon Biologics CEO Christiane Hamacher said.
The introduction of both 420 mg multi-use vials and 150 mg single-use vials of a high quality biosimilar trastuzumab with robust long-term efficacy and safety data will offer greater choice and value to patients, prescribers and payors in the US, she added.
"We aspire to serve 5 million patients through our biosimilars portfolio and cross a revenue milestone of USD 1 billion by FY22," Hamacher said.
Ogivri was the first biosimilar trastuzumab approved by the United States Food and Drug Administration (USFDA), the statement said.
It is approved for all indications of Herceptin including for the treatment of HER2-overexpressing breast cancer and metastatic stomach cancer, it added.
"As one of the largest suppliers of oncology medicines in the US, we are proud to offer Ogivri, biosimilar trastuzumab, in both the 420 mg and 150 mg strengths and help increase more affordable access to this important treatment option for breast and gastric cancer patients," Mylan President Rajiv Malik said.
With regulatory approval for "our biosimilar trastuzumab in more than 80 countries worldwide, we are bringing vast global biosimilars experience to the US and look forward to continuing our work with all stakeholders in the healthcare system to reduce costs, improve access and advance care," he added.
Ogivri is the second biosimilar to be offered by Mylan through the Mylan-Biocon Biologics partnership in the US and the second FDA-approved biosimilar through this collaboration to support cancer patients, the statement said.
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