APRIL, 2020 | THE HEALTH
| Insight |
Biosimilars a timely
boost fo r kidney patients
T
HERE is a perception that the
eff ectiveness or effi cacy of
biosimilar products may not be
as good as the originals. As such,
having to choose between an
original and a biosimilar can
be a challenge for some doctors
and patients.
But according to Dato’ Dr Zaki Morad
Mohamad Zaher, Consultant Nephrologist
at KPJ Ampang Puteri Specialist Hospital,
biosimilars can be as eff ective as the
originals.
A biosimilar is a ratifi ed product that
is produced based on an original product
approved by the US Food and Drug
Administration (USFDA). It is formulated
from a cell line from living organisms and
is, therefore, not identical with the original
product but has a similar and equal eff ect.
A biosimilar product undergoes a
series of rigorous tests before it can be
registered. They include laboratory tests,
animal studies and studies in humans.
The latter includes a phase 1 study where
it is used for the fi rst time in healthy
human volunteers. A phase 2 human study
investigates the use in a small number
of patients with the condition for which
the product is targeted. A phase 3 clinical
trial is a larger trial where the biosimilar
is compared against the original product
in the target population for which it
is indicated. Following satisfactory
outcomes in all these studies, the product
will be submitted for registration.
Patients may ask if biosimilar
products can be as efficient as the
originals. That is why clinical trials
are carried out for biosimilar products
to prove the point on their
effective-ness.” — Dato’ Dr Zaki Morad
There are a few reasons for the
existence of biosimilar products.
“Firstly, it is due to the expiry of the patents
for drugs. Original products can continue
to be produced by the innovator company
for a certain duration following which
other companies have the right to develop
similar ones. This opens up opportunities
for products,” explained Dato’ Dr Zaki.
Dato’ Dr Zaki said prescription of
biosimilar products might raise concerns
from patients on their effi cacy, cost and
side eff ects.
“Patients may ask if biosimilar products
can be as effi cient as the originals. That
is why clinical trials are carried out for
biosimilar products to prove the point on
their eff ectiveness.
“Secondly, the concern would be
the cost. Biosimilars are expected to be
cheaper compared to the original product.
If it costs more, people might as well
revert to the original product,” said
Dato’ Dr Zaki.
As for side eff ects, he said that goes for
any original product, not only biosimilars.
A biosimilar which has the same expected
outcome as the original, can be expected to
have a similar side eff ects profi le Although
most physicians would usually recommend
original products, biosimilar products can
benefi t the patients in terms of providing
a cheaper option. Patients will have the
alternative of paying less for a similar eff ect.
“At present, we have one biosimilar
product released in Malaysia. It is made
from a certain cell line and produces an
erythropoiesis-stimulating agents (ESA),”
he said.
An ESA is the synthetic form of
a naturally produced hormone that
stimulates the bone marrow to produce
hemoglobin, the protein in our red cells
that binds with oxygen and carries them
to our tissues. The hormone is produced by
the kidney and is defi cient in kidney failure
patients. According to Dato’ Dr Zaki, there
were three to four original products of this
kind. The new biosimilar Erythropoietin
has shown a similar improvement in
Hemoglobin level and side eff ect profi le as
the original. — The Health
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