Philadelphia Medicine Summer 2021 - 21

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$2.6 billion to develop, " Kelton said. " A biosimilar may involve a
time investment of five to nine years or more and cost more than
$100 million to develop, whereas development of a small-molecule
generic may take up to 2 years and cost $1 million to $4 million. "
The big players in retail pharmacy such as CVS and Rite Aid
address biologics on their websites.
CVS/Caremark's website states it is dedicated to helping physicians
manage and help their patients who are suffering from complex
disorders and require specialized therapies.
The website dedicates a page to biologics: " A new, rapidly growing
category of drugs, specialty pharmaceuticals are the result of continued
advances in drug development technology and design. They are created
to target and treat medical conditions and include bioengineered
proteins, blood-driven products and complex molecules. "
Rite-Aid, likewise, advertises the same services through its Envision
Specialty Pharmacy, a wholly owned subsidiary of Rite Aid.
Envision Rx says it provides pharmacy services to patients who
require specialty medications, injectable pharmaceuticals and complex
treatment regimens.
Still in infancy
Many within the pharmaceutical
industry would say that biologics and
biosimilars are still in their infancy.
Maria Tomoiaga, PharmD, is a
pharmacy fellow with Novartis in
clinical quality assurance, and served
one of her rotations with the FDA.
Tomoiaga said because biologics
and biosimilars are relatively new
to the pharmaceutical industry, no
classes were taught specifically on biologics
while she was a student at the
Philadelphia College of Pharmacy.
" When we got to complex autoimmune diseases, that's when we
were introduced to these types of drugs, " Tomoiaga said. " The whole
market for biologics has been growing and, with more development
in biologics, we now see advocacy groups.
" These are grass roots efforts in helping to spread the word, " she
said. " Often times families have been afflicted by hard-to-treat disease
and they organize groups to advocate what treatments are available. "
Tomoiaga said she believes biosimilar medications will play an
'Biologics enables highly
personalized treatment options
that have life-saving potential, and
is an expanding area of research.'
- Maria Tomoiaga, pharmacy fellow
with Novartis
important role in treatments, since their efficacy and safety remains
the same as the original biologic.
" Biologics enables highly personalized treatment options that
have life-saving potential, and is an expanding area of research, "
Tomoiaga said.
Kelton said there is definitely an important role for biosimilars
in the pharmaceutical world.
" Biosimilars and the biosimilar pathway facilitate competition
for existing biologics after they lose exclusivity, and this may drive
competition to create new and improved biologics, " Kelton said.
" Over time, improvements in the biosimilar development process
as well as manufacturing and analysis techniques may help reduce
development costs for these medicines, which provide value to the
health care system by driving market competition that can lower
the cost of care. "
*
David A. Kostival is a contrbuting writer to Philadelphia Medicine.
Summer 2021 : Philadelphia Medicine 21
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Philadelphia Medicine Summer 2021

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