India’s Biosimilars Guidelines Lay Out Best Practices But Marketed Products Not To Be Reviewed – BIO Conference
This article was originally published in PharmAsia News
Executive Summary
The guidelines will enable a standardized biosimilars pathway as opposed to case-by-case application reviews
You may also be interested in...
Roche Lashes Out At Biosimilars Regulations In Emerging Markets, Calls For Stricter Pharmacovigilance Of Launched Products
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)
United We Stand: Regulatory Framework For Biosimilars May Bring Indian And MNCs Closer
HYDERABAD - Amid numerous fights over patents of leading drug brands, Indian and multinational drug companies may be seeing some sense in working cohesively to help the Indian government establish standard regulations and allow development and launch of future biosimilars and novel biotechnology-based drugs
Indian Investors Turn Cautious On Compliance Concerns
A rising number of enforcement actions by major drug regulators like the U.S. FDA is slowly making investors cautious about the longer term repercussions on earnings of Indian drug makers.