January 24, 2013

Biosimilar Regulatory Guidelines in Emerging Markets – India

Biosimilar Regulatory Guidelines in Emerging Markets – India

For companies embarking on a biosimilar drug development program, the goal is clear, but the road to get there is less so. If you can scientifically demonstrate that a biologic product is highly similar to the approved biologic, you’ll be able to abbreviate and reduce the burden of preclinical and clinical trials data package as part of submission for market authorization.

The Indian Government has developed and issued guidelines which apply to similar biologics that contain well characterized proteins as their active substance, derived through modern biotechnological methods such as the use of recombinant DNA technology.

In this presentation, a detailed description of the requirements for registration and post-marketing, as well as a Pharmacovigilance plan will be discussed.

CEOs, Directors, VP, Heads and Team Leaders from

• Legislation and Policy Advice
• Biosimilar Strategists
• Business Development – Emerging Markets
• Manufacturing
• Drug Development
• Bioequivalence
• Drug and Safety Assessment
• Market Strategy
• Regulatory Affairs
• APIs
• Intellectual Property
• Pricing Lead/ Project Lead

Vijay Tammara, VP Global Regulatory Affairs, Nuron Biotech, AAPS Member

Dr. Vijay Tammara is currently VP, Global Regulatory Affairs at Nuron Biotech Inc. He joined Nuron Biotech Inc., in October 2010. He is an experienced regulatory scientist with about 18 years of leadership experience in the field of regulatory science and strategic clinical drug development.

Previously during his tenure at Merck, Dr. Tammara has made significant contributions to the approval of several products including Emend, Emend IV, Vytorin, and Cozaar-XQ.

Dr. Tammara is an Editor for the Journal, “Clinical Research and Regulatory Affairs”, and an adjunct faculty at University of Pacific, Stockton, University of Louisiana, Monroe, and SIUE, St.Louis. His research interests include: Regulatory Science with special emphasis on BA/BE, In Vitro, In Vivo correlations, PK/PD relationships, Drug-Drug Interactions, and Pediatric Drug Development.

Dr. Tammara is an AAPS Fellow and has been an active member of AAPS since 1988, contributing to many of its educational programs, and has been Past Chair for the RS section. He also received an AAPS Regulatory Sciences Achievement Award in 2012. He has served on several other committees at AAPS and has organized and chaired several symposia, workshops, round tables, sunrise sessions, satellite sessions, open sessions for hot topics, open forums, poster-podium sessions, poster sessions, and short courses at national meetings.

Dr. Tammara previously served as a Director, Regulatory Affairs at Merck & Co., Inc., Senior Associate Director at Wyeth Pharmaceuticals and as an Assistant Director at Sanofi-Synthelabo in Worldwide Regulatory Affairs. Prior to his industrial positions, he held increasingly responsible positions in the Office of Clinical Pharmacology and Biopharmaceutics at the FDA.

Dr. Tammara received several FDA awards including the CDER Outstanding Reviewer Award, FDA Outstanding Achievement Award, Group Recognition Awards, Center Director’s Special Citation Awards, CDER Team Excellence Awards, Team Spirit Awards, and Awards of Excellence. He also received awards in the Pharmaceutical Industry including Merck’s Awards of Excellence in 2004, 2005, 2007, 2009, and 2010 and Special Recognition Awards in 2007, 2008, 2009, and 2010. He addtionally received several AAPS-RS Awards including RS Section Recognition Awards in 2004, 2006, 2007 and 2010.

Dr. Tammara received his Ph.D. in Pharmaceutics from the University of Louisiana, Monroe, LA, graudating with a School of Pharmacy Research Achievement Award, in 1993. He is a member of Rho Chi, Phi Delta Chi, and Phi Kappa Phi honor societies.