Education Sessions
Follow On Biologics – A Panel Discussion (105)
| 29 October 08.15-11.15 | Track: Regulatory |
ISPE CEUs: 0.2
(PDF Current as of 9 October 2008)
Several smaller molecule biologics like Insulin and HGH, made using r-DNA technology, are already being marketed by multiple manufacturers. It is estimated that biologics worth $10 billion will be off patent by the year 2010 and that by 2015 the market value of off patent biologics is expected to top $20 billion. It is therefore no surprise that the market place is extremely interested in the fate of biogenerics, biosimilars or follow on biologics. This session is being offered to stimulate the healthy debate required to create a well thought out and defined pathway for Follow on Biologics without risking drug safety and efficacy.
The biogeneric manufacturers will have to face the unique challenges associated with replicating large molecule biologics. In addition, should they also be required to submit evidence of drug safety and efficacy, which may be even more stringent than that provided for the original?
As a part of this session the panelists will explore and debate:
- Economic and Financial Issues
- Legal/Patent Issues
- Technical Issues
- Regulatory Issues
The panel discussion format will not only create an opportunity to see the same issues explored from differing perspectives, but also allow the attendees to become active participants in the discussion.
How You Will Benefit
At the end of this session, participants will be able to:
- Develop a comprehensive understanding of issues and challenges associated with Follow on Biologics
- Explain differing views on the issues within the marketplace
Who Should Attend
Owners, developers and designers, of biopharmaceutical processes and facilities as well as regulatory and quality professionals involved in product and facility validation and approval/licensing processes
ISPE Communities of Practice (COPs)
Biotechnology (Biotech)
Session Leader
- Deepak Agarwal, Director, Pharma Technology, Jacobs Consultancy, USA
Session Speakers
- Raymond Arner, Principal, Miller, Canfield, Paddock & Stone PLC, USA
- Steven Kozlowski, Director, Office of Biotechnology, OPS, FDA, USA
- Anthony Lubiniecki, Vice President, Centocor, USA
- Anthony Ridgway, Senior Regulatory Scientist, Health Canada, Canada
- Ramaiyer Srinivasan, Engg Services, The Himalaya Drug Company, India
- Raman Srinivasan, , Biocon, India