By: Erika Johnson, Senior Associate
Erikajohnson@cis-partners.com
On February 9, 2012, the U.S. Department of Health and Human Services
Food and Drug Administration released the following three draft
guidance documents on Biosimilarity: Scientific Considerations in Demonstrating Biosimilarity to a Reference Product, Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product, and Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009.[1]
Before looking at this newly released draft guidance, it is important
to understand the history of biosimilars in order to appreciate the
value of this recent release.
According to the FDA website, “a biosimilar is a biological product
that is highly similar to a U.S.-licensed reference biological product
notwithstanding minor differences in clinically inactive components, and
for which there are no clinically meaningful differences between the
biological product and the reference product in terms of the safety,
purity, and potency of the product.”[2]
Additionally, a biological product “can include a wide range of
products including vaccines, blood and blood components, allergenics,
somatic cells, gene therapy, tissues, and proteins.”[3] Biological products are generally [not in all cases but generally] licensed through the Public Health Service Act (PHS Act).[4]
Biosimilar biological products differ from generic drugs in that
generic drugs are “small-molecule drugs that are the same as, and
bioequivalent to, and already-approved small-molecule drug regulated
under the [Food, Drug and Cosmetic Act] FD&C Act”.[5]
http://www.pharmacomplianceblog.com/blog/?p=4492
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