Philadelphia Medicine Summer 2021 - 20

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FEATURE continued
biologic drug development pathway is utilized to demonstrate the
safety and efficacy of the biologic in patients. "
No meaningful differences
Kelton said the goals of a biosimilar developer are to create a
version of an existing biologic that is structurally and functionally
as close as possible to an existing well-studied product in order
for it to perform with no clinical meaningful differences from the
reference biologic.
According to Kelton, the first biosimilar approval in Europe
occurred in 2006, and was followed in the United States in 2015.
" The science and technology required to develop biosimilars evolved
from the decades of global experience gained from the manufacturing
and development of modern recombinant biologics, which were
initially approved in the United States in the 1980s, " he said.
When it comes to the practicality
of paying for biologics, insurance
companies typically prevent independent
retail pharmacies from filling
prescriptions.
But there is a pathway available.
Sam Maddula, PharmD, is the
CEO/pharmacist in charge of Banks
Apothecary Specialty Pharmacy in
Trevose, Bucks County, which has
the ability to fill prescriptions for
biologics.
Maddula said his specialty pharmacy
has accreditations from the Accreditation Commission for
Health Care and the Utilization Review Accreditation Commission.
Maddula referred to the URAC as the " gold standard of accreditation. "
Among other benefits, these accreditations allow his pharmacy to
be designated as a specialty pharmacy and target a specific population
with chronic and sometimes life-threatening diseases.
Because of the restrictions placed by insurance companies, Maddula
said typical mom-and-pop independent pharmacies cannot get
authorized to bill for a biologic.
Popular biologic
Maddula said one of the most popular biologics is Humira, which
is an injectable used to treat rheumatoid arthritis, psoriatic arthritis,
Crohn's disease and chronic plaque psoriasis.
Another is Enbrel, which is also
used to treat rheumatoid arthritis
and psoriatic arthritis.
Maddula said the one drawback
he sees to biosimilars is that they
seem harder to get FDA approval.
" It may make more financial
sense (for pharmaceutical companies)
to invest in biologics and
get extensions on their patents, "
Maddula said.
The expense of biologics can
play a major factor.
According to the website Drugs.com, the average out-of-pocket
cash price without insurance for a 30-day supply of Humira is
about $6,240.
With insurance, co-pays can range from $5 to more than $300.
Kelton said the costs of biologics, as well as biosimilars, are
based on the fact that these require a substantial time and financial
investment.
" A novel new biologic may take a decade, at cost estimates up to
" Once you have the accreditation, that basically shows the insurance
payer that this pharmacy has gone through more rigorous standards
to ensure giving quality care, " Maddula said.
One of those standards includes keeping clinical charts on patients,
similar to a doctor's office.
But Maddula points out that having the accreditation does not
make a pharmacy better than one without the accreditation.
" It just gives me an opportunity to get through to bill for specialty
medications, " he said.
20 Philadelphia Medicine : Summer 2021
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Philadelphia Medicine Summer 2021

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