Roche Lashes Out At Biosimilars Regulations In Emerging Markets, Calls For Stricter Pharmacovigilance Of Launched Products
This article was originally published in PharmAsia News
Executive Summary
MUMBAI - Roche - maker of blockbuster biotech products like Avastin and Mabthera - has called for a stricter regulatory and approval mechanism for biosimilars being launched in markets like India even as the European Union rolled out its draft guidelines for developing biosimilar versions of complex monoclonal antibodies Nov. 26 (EU Draft Guidelines On Biosimilar Antibodies Go Easy On Generics Firms, But Originators Need Not Panic, The Pink Sheet DAILY, Nov. 29, 2010)