Biocon receives USFDA approval for Ogivri, the first biosimilar for Trastuzumab
The drug regulator, USFDA (US Food and Drug Authority), approves Mylan and Biocon’s co-developed product, Ogivri, the first biosimilar for Trastuzumab for treatment of HER2-Positive breast and gastric cancers.
Ogivri is the first FDA approved biosimilar to Herceptin and the first biosimilar from Mylan and Biocon’s joint portfolio in the US. 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.
Mylan and Biocon’s biosimilar for Herceptin is also 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 affordable biologic for cancer patients.
Mylan and Biocon are exclusive partners on a broad portfolio of biosimilar and insulin products. Biosimilar for Herceptin is one of the six biologic products co-developed by the company.
The stock of Biocon Ltd closed at a price of Rs 446.55, up by 3.31% or Rs 14.30 on December 1, 2017.