Learning from History: Making Biosimilars a Reality
- Broadcast Date:
Thursday, November 1, 2012
1:00 pm ET, 10:00 am PT
REGISTRATION IS FREE
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—and thus bring to bear the intended benefits of the Public Health Services Act. Here’s the issue: how do you precisely go about adequately demonstrating comparability between a biosimilar and its originator? There is no silver bullet analytical program that will make sense for every biologic. It will depend on the molecule, and every molecule is different. And if the copy and original are shown to be essentially the same, a new consideration arises: immunogenicity. The FDA’s guidance can provide useful perspective. It’s also important to recognize that this road is not entirely new, and we can learn from biologic drugs that have undergone similar approvals both in the U.S. and in Europe. What can we learn from the past to help guide the future?
In this webinar, industry thought leaders will present the FDA’s latest thinking on biosimilar approvals and will teach from experience on how to structure your approach. The head of global pharmaceutical development at Sandoz, the first company in the EU to receive biosimilar approval, will demonstrate their biosimilar development model with an emphasis on analytical characterization tools that reduce uncertainty for regulatory authorities and set the foundation for shortened preclinical and clinical programs. The chemistry and chemical biology department head at Northeastern University will talk about how modern techniques can help improve the physiochemical characterization of your biologics. Finally, the senior scientific director of Large Molecule Bioanalysis at WIL Research, a preclinical CRO that has successfully characterized the properties of biosimilar drugs in the U.S., will focus on two of the most important and most difficult aspects of biosimilar clinical testing: providing evidence of bioequivalency and immunogenicity.
In This Webinar You Will Learn
- A model for establishing a fingerprint through bioanalytical methods that would demonstrate that your biosimilar is “highly similar” to the originator
- Real-world guidance on two of the most important and most technically challenging aspects of biosimilar clinical testing: bioequivalency and immunogenicity
- Primer on modern techniques—and their limitations—for the physiochemical characterization of the innovator product and proposed biosimilar, including higher-order structure and post-translational modifications
Who Should Attend
- Companies embarking on biosimilars development interested in testing and comparing their biosimilars to patented drugs
- Protein biochemists
- Protein analytical and bioanalytical scientists
- Drug development toxicologists and study directors
A live Q&A session will follow the presentations,
offering you a chance to pose questions to our expert panelists.