Philadelphia Medicine Summer 2021 - 19

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Licensure pathway
The U.S. Food and Drug Administration states that through the
Biologics Price Competition and Innovation Act of 2009, Congress
approved an abbreviated licensure pathway for biological products
that are shown to be interchangeable, or " biosimilar, " with an
FDA-approved biological product.
The whole idea of a biosimilar is that it is meant to control
biologic prices after a biologic's patent expires.
John Kelton, medical director,
biosimilars, at Pfizer, explained
that biosimilars have the potential
ability to treat the same medical
conditions as biologics and be
equally effective.
" The primary benefits of biosimilars,
which are highly similar
versions of some of the most widely
prescribed biologic therapies, are a provision of increased price competition
while providing additional treatment options, as well as the
generation of potential savings for health care systems. " Kelton said.
But Kelton stressed that it is important to recognize that biosimilars
are, in fact, biologic drugs.
" Biological products include a wide range of products such as
vaccines, blood and blood components, allergenics, somatic cells, gene
therapy, tissues and recombinant therapeutic proteins, " Kelton said.
Kelton said biologics can be composed of sugars, proteins, nucleic
acids or complex combinations of these substances, or could also be
living entities such as cells and tissues.
" Typically, a novel new biologic is developed to fulfill an unmet
clinical need, with a goal of improving upon existing standards
of care, " Kelton said. " These biologics may have a structure and
mechanism of action never evaluated in patients previously. As
such, critical information about structure as it relates to biologic
function may not be well-understood, hence the traditional new
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'When we got to complex autoimmune diseases, that's when we were introduced
to these types of drugs. The whole market for biologics has been growing
and, with more development in biologics, we now see advocacy groups.'
- Maria Tomoiaga, pharmacy fellow with Novartis
Summer 2021 : Philadelphia Medicine 19

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Philadelphia Medicine Summer 2021

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