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....learn more
INTERVIEW:
GENE THERAPY FOR FATAL NEURODEGENERATIVE DISEASE IN CHILDREN - Interview with Ronald G. Crystal, M.D., Professor and Chairman of the Department of Genetic Medicine of the Weill Medical College of Cornell University
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