FDA Approves First Biosimilar to Roche’s Herceptin

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FDA has approved Mylan’s biosimilar to Roche’s blockbuster anti-cancer biologic, Herceptin.

FDA has approved Mylan’s Ogivri (trastuzumab-dkst), a biosimilar to Roche’s Herceptin (trastuzumab), for treating breast or metastatic stomach cancer in patients whose tumors overexpress the HER2 gene (HER2+), the agency announced on Dec. 1, 2017. Ogivri is the first biosimilar approved in the United States for treating breast and stomach cancers and the second biosimilar approved in the US for cancer, according to FDA.

Herceptin, approved by FDA in September 1998 and one of Roche’s top-selling drugs, had US sales of more than $2 billion for the 12 months ending Sep. 30, 2017, according to IQVIA (formerly QuintilesIMS).

Ogivri is the first biosimilar to Herceptin that is approved in the US and the first biosimilar approved in the US from a joint portfolio by Mylan and Biocon, an Indian biopharmaceutical company, according to the companies. Mylan expects to potentially be the first to offer a biosimilar to Herceptin due to its securing of global licenses for its trastuzumab product from Roche and its subsidiary, Genentech, earlier in 2017. This move allows Mylan to commercialize its trastuzumab product in various global markets.

The biosimilar product is also under review by regulatory authorities in Australia, Canada, Europe, and several additional markets. It is already approved in 19 countries worldwide, including India. The labeling for Ogivri, like Herceptin, includes a boxed warning to alert health care professionals and patients about increased risks of heart disease (cardiomyopathy), infusions reactions, lung damage (pulmonary toxicity), and harm to a developing fetus (embryo-fetal toxicity).


The biosimilar is one of six biologic products being co-developed by Mylan and Biocon, which are exclusive partners on a broad portfolio of biosimilar and insulin products. Mylan has exclusive commercialization rights for the product in the US, Canada, Japan, Australia, New Zealand, and European Union and European Free Trade Association countries. Biocon has co-exclusive commercialization rights with Mylan for the product in the rest of the world.

Source: FDA, Mylan