Mylan and Biocon’s Ogivri is the first biosimilar of Herceptin to win US approval, for certain breast cancer and metastatic stomach cancers.
The US Food and Drug Administration has cleared the drug’s use for the treatment of patients with breast or metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma) whose tumors overexpress the HER2 gene.
Ogivri’s clearance is based on a review of evidence that included extensive structural and functional characterisation, animal study data, human pharmacokinetic and pharmacodynamic data, clinical immunogenicity data and other clinical safety and effectiveness data that demonstrates its biosimilarity to Herceptin (trastuzumab).
Like Herceptin, the labeling for Ogivri (trastuzumab-dkst) contains a Boxed Warning to alert healthcare professionals and patients on increased risks of heart disease, infusions reactions, lung damage and harm to a developing fetus.
"The approval of Ogivri represents a monumental achievement for Mylan to increase patient access to biosimilars and deliver significant savings to the US healthcare system,” said Mylan’s chief executive Mylan chief executive Heather Bresch.
“It will allow us to bring this important biosimilar – the first of its kind – to market in the US, expanding cancer-patient access to more affordable treatment.”
Mylan and Biocon's biosimilar for Herceptin also is under review by regulatory authorities in Australia, Canada, Europe and several additional markets. It is already approved in 19 countries around the world, including India, “thus providing increased access to this more affordable biologic for cancer patients”.