Biosimilars and Follow-On Biologics 2014 Americas
Organization: Paradigm Global Events
|Event Date/Time: Feb 10, 2014||End Date/Time: Feb 12, 2014|
Biosimilars also known as Follow-on Biologics or subsequent entry biologics are official subsequent version of innovator pharmaceutical products on which reference to the innovator product is crucial component for approval.
This conference examines a number of challenges including commercial, regulatory, and technical, all of them in turn and discusses for example: the current commercial trends of biosimilars; what the commercial impact of them is; and what is happening in the BRIC countries.
The conference also looks at the latest global regulatory guidelines and issues surrounding biosimilars and what this means for the data exclusivity, is there a need for a balance between innovation and competition?
Technical issues with biosimilars however are the major concern. Biological drugs unlike the more common small-molecule drugs maybe more sensitive to changes in manufacturing process due to its high molecular complexity, so biosimilar producers have to prove that the overall effects are the same.
Following the success of the first generation Monoclonal antibodies blockbusters, here we analyze many challenges to be faced to bring more efficient and affordable anti-body based drugs to the market.
Finally, biobetters are a new category of drug: why just copy a drug when you can improve it? This workshop examines the potential of biobetters for companies and how to maximize opportunities.
Why you should attend this conference
- Gain a better understanding of the global regulations and guidelines for Biosimilars including variations and new developments
- Explore clinical and preclinical challenges in the development of biosimilars
- Identify challenges encountered with specific product manufacturing
- Examine the issues of conducting trials, assessing immunogenicity and pharmacovigilance
- Explore CMC requirements in order to produce high quality similar biologic product
- Focus on issues in developing biosimilars mAbs
- Learn how the BRIC market is dealing with Biosimilars
- Network with experts and leaders of the induustry
I look forward to meeting you at the conference.
Jocelyn Raguindin Conference Director Info@paradigmglobalevents.com