Shares of Biocon rallied 15% after the drug regulator, USFDA approves Mylan and Biocon's co-developed product, Ogivri, the first biosimilar for Trastuzumab for treatment of HER2-Positive breast and gastric cancers.
The FDA in September approved Amgen Inc's biosimilar version of Avastin. "This is especially important when it comes to diseases like cancer, that have a high cost burden for patients", said FDA Commissioner Scott Gottlieb. Mylan is a global leader in the development and manufacturing of complex products, including biosimilar medicines, with a portfolio of 16 biosimilar and insulin analog products.
Shares of Biocon today surged as much as 14 per cent in morning trade after the biotechnology major said it has received regulatory approval to market a biosimilar of cancer drug Herceptin in the United States.
This is the first US/EU biosimilar approval for the partnership, allaying concerns over compliance with manufacturing standards, potentially paving the way for Biocon's biosimiliar of chemotherapy drug Neulasta in Q1 2018, according to Kotak Securities analysts.
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 FDA approved Mylan's Ogivri to treat certain types of breast and stomach cancers.
This milestone secured a clear pathway to commercialize Mylan's biosimilar to Herceptin in various markets globally.