The biosimilar - developed by Mylan and Biocon and called Ogivri (trastuzumab-dkst) - has been approved by the FDA for HER2-positive breast or metastatic stomach cancer, the same indications as Herceptin which brought in nearly $7bn in sales a year ago, around $2.5bn of that total from the United States market.
"Ogivri has been approved for all indications of the reference product, Herceptin, including for the treatment of HER2-overexpressing breast cancer and metastatic stomach cancer".
The US Food and Drug Administration (FDA) on Friday approved the first biosimilar to Roche's blockbuster breast and stomach cancer drug Herceptin (trastuzumab). The companies secured global licenses for its product from Herceptin's producer, Genentech, earlier this year.
"FDA approval for Trastuzumab validates Biocon's capabilities in biosimilars, eases manufacturing concerns and potentially improves its ability to get approvals in other markets".
The FDA's approval of the biosimilar is based on review of evidence that included extensive structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamic data, clinical immunogenicity data and other clinical safety and effectiveness data that demonstrates Ogivri is biosimilar to Herceptin. The labeling for trastuzumab-dkst carries a boxed warning alerting health care professionals and patients to increased risks of heart disease (cardiomyopathy), infusions reactions, lung damage (pulmonary toxicity), and harm to a developing fetus (embryo-fetal toxicity).
It is already approved in 19 countries around the world, including India, thus providing increased access to this more affordable biologic for cancer patients, it added. "We now look forward to moving ahead with the rest of the regulatory review process in Europe and to bringing these important treatment options to cancer patients".