Presents an Educational and Informative Audio Webinar
Biosimilars: Toward a Scientific and Regulatory Consensus
Original Broadcast Date Wednesday, June 11, 2008
Time 1:00 – 2:00 pm EST
Scientists and regulatory and business development professionals involved in the introduction of biosimilars, also known as biogenerics and follow-on biologics, need to attend this free webinar — Biosimilars: Toward a Scientific and Regulatory Consensus.
Who will benefit from attending this webinar:
- Protein therapeutic discovery scientists
- Biochemists who characterize biotherapeutic proteins
- Regulatory affairs professionals who need to know the current status of biosimilars in the U.S., the EU, and key Asian markets
- Business development managers seeking to enter the potentially lucrative field of biosimilars
- Contract biomanufacturers, through whose efforts the first wave of biosimilar proteins will be produced into U.S. markets
- Quality control and analytical scientists at innovator biotech companies and contract manufacturers
Key learning points for this webinar:
- Introduction to biosimilars — how are they defined?
- Perspectives from innovator companies: What science and marketing needs to do before biosimilars become a reality
- Perspectives from contract manufacturers: Key aspects of the transfer of manufacturing and analytic technologies
- Analytical methods most suited to characterizing biosimilars for chemical structure, biological activity, and safety factors
Biosimilars will be critical to the competitiveness of the U.S. biopharmaceutical industry over the next decade. However, the "bio" counterpart of the Hatch-Waxman Act, which essentially created the U.S. small molecule generic pharmaceutical industry, does not yet exist. Nor have appropriate regulations been drawn up by the U.S. FDA. Lacking the legal foundation enjoyed by small molecule drugs, biosimilars have languished in a kind of regulatory limbo.
Key to resolving the legal and regulatory issues will be the development of appropriate analytical techniques for characterizing biosimilars. Because of their infinitely more complex chemical makeup, proteins cannot be analyzed as straightforwardly as small molecule drugs. When regulations are eventually drawn up, manufacturers will likely need to demonstrate similarity at several levels through multiple robust, reliable, orthogonal techniques.
This webinar will discuss the most relevant legal and regulatory issues surrounding biosimilars and examine the most appropriate analytical methods.
PANELISTS
Charles DiLiberti
Vice President Pharmacokinetics and Bioequivalence,
Barr Laboratories, Inc.
Gillian R. Woollett, M.A.,
D.Phil., Chief Scientist,
Engel & Novitt, LLP
Jeff Mazzeo, Ph.D.
Biopharmaceutical Business Director
Waters Corporation
MODERATOR
John Sterling
Editor in Chief
Genetic Engineering
& Biotechnology News
Produced with support from Waters Corporation
