Biocon And Mylan Launch Trastuzumab Biosimilar Ogivri In US

Biocon on Monday announced the US launch of Ogivri (trastuzumab-dkst), a biosimilar to Herceptin (trastuzumab). Ogivri is available in a 420mg multi-dose vial and a 150mg single-dose vial to provide patient dosing and treatment flexibility.

Two supplemental Biologics License Applications were recently approved by the FDA, expanding the manufacturing capability for Ogivri, as well as Mylan and Biocon’s first US biosimilar, Fulphila”, a biosimilar to Neulasta”, Biocon said in the filing. Mylan and Biocon Biologics have sufficient manufacturing capacity to fulfil demand in the US and global markets for both products.

Ogivri was the first biosimilar trastuzumab approved by the US Food and Drug Administration (FDA) and unanimously recommended by the FDA Oncologic Drugs Advisory Committee (ODAC). Ogivri is approved for all indications of Herceptin including for the treatment of HER2-overexpressing breast cancer and metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma). Trastuzumab and biosimilar trastuzumab products contain a Boxed Warning for cardiomyopathy, infusion reactions, pulmonary toxicity and embryo-fetal toxicity, the pharma company added.

Dr Christiane Hamacher, CEO, Biocon Biologics said, “the US launch of Ogivri, the biosimilar trastuzumab co-developed by Biocon Biologics and My/an, marks a significant milestone in our biosimilars journey. It is an important endorsement of our science, development and manufacturing capabilities in the area of monoclonal antibodies. The introduction of both 420mg multi-use vials and 150mg single-use vials of 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. As a global frontrunner in biosimilars, Biocon Biologics is committed to fulfilling unmet patient needs by providing greater affordability for enhanced patient access. We aspire to serve 5 million patients through our biosimilars portfolio and cross a revenue milestone of US$ 1 bn by FY22.

“Ogivri is the second biosimilar from our partnered portfolio being commercialized by My/an in the US Last year, through the launch of Fulphila we helped in expanding patient access to biosimilar Pegfilgrastim,” Dr Christiane added. –India Infoline