16
THE HEALTH | APRIL, 2020
| Insight |
Early
screening
vital in
treating
kidney
disease
E
Duopharma sets
frontier for biosimilars
D
UOPHARMA Biotech Berhad
is the FIRST Malaysian
company to co-develop a
bio-therapeutic product, an
epoetin alfa (EPO alfa) for
anemia in renal patients.
It was in collaboration
with PanGen Biotech Inc.
of South Korea. This will contribute
to economic growth and the local
pharmaceutical industry.
According to Noor Aida Jaafar,
General Manager of Ethical Specialty
Business of Duopharma, the product
was fi rst approved in Malaysia and
since April 2019, Duopharma started
commercialising its Epoetin Alfa
Biosimilar in the Malaysian market.
Duopharma sees the birth of
this true biosimilar as a milestone
national interest project. It is not only
manufactured for the local market but
is also targeted for export. The product
has established its bio similarity and
granted its approval from the National
Pharmaceutical Regulatory Agency
(NPRA) after a four-year clinical trial.
This is a massive accomplishment for
Malaysia featuring its epoetin alfa.
In addition to this, the product will
be produced from Duopharma fi ll
and fi nish facility (fi rst of its kind in
Malaysia) for local and export
supply.
“The benefi ts of producing our
biosimilar product is we can replace
imported products and improve
technology ‘’know-how’’ and capabilities
in manufacturing biosimilars. This
would be a socioeconomic value add as
we increase the export of Malaysian
products.”
An advantage for patients is it reduces
their fi nancial burden. Biosimilars cost
less compared to reference products.
If patients start to opt for biosimilar
products, their small savings will
The benefits
of producing
our biosimilar
product is we
can replace
imported
products
and improve
technology
‘’know-
how’’ and
capabilities in
manufacturing
biosimilars.
This
would be a
socioeconomic
value add as
we increase
the export
of Malaysian
products.”
— Noor Aida Jaafar
snowball into more signifi cant savings.
“In producing a biosimilar, our
biggest contribution will be reducing
the predatory pricing by innovators.
We remain committed to the mission
of ensuring that quality treatment
becomes accessible to all,” said Aida.
People’s perception of a biosimilar
product must change. According to
Aida, many professionals are still not
aware of the classifi cations of biologics.
The term ‘biosimilar’ is typically used
to generalise all biologics apart from
innovators.
There has been a sub-classifi cation of
biologics – stand-alone and biosimilar.
Many EPO products registered as
“Stand-alone” in outside of developed
countries. These “Stand-alone” EPO
therapeutics have never been compared
with innovators’ products in terms of
Quality, Safety, and Effi cacy; very poor
Post Marketing Surveillance (PMS)
studies after registration.
Aida said: ‘’The ministry has been
supportive of local products. They are
working to assist us in bringing the
products in faster as it has long-term
cost benefi ts to the patient. Expediting
approval will be a win-win for all
stakeholders while healthy competition
adds value to all parties. We are
proactively engaging with the Ministry
to facilitate these outcomes and
charting the future direction.”
Duopharma went to great lengths
to create this biosimilar product. After
investing RM22 million just on clinical
trials, its biosimilar epoetin alfa has
proven to be equally as good as the
reference product.
So, people need to understand that a
biosimilar will only be approved once
its biosimilarity is proven in both safety
and effi cacy compared to the reference
product. Therefore, the quality of a
biosimilar is high. — The Health
VERYONE should value their
kidney health and get access
to early kidney screening
to prevent the disease from
progressing said Consultant
Physician and Nephrologist
Professor Dr Abdul Halim Abdul
Gafor.
“It is vital to have access to care for our
kidney. This includes early screening as
well as seeking treatment for prevention,”
said Dr Halim who is also deputy director
at Hospital Canselor Tuanku Muhriz,
Universiti Kebangsaan Malaysia Medical
Centre (UKMMC),
A yearly campaign, ‘The World Kidney
Day’ is a way of bringing people together
to generate awareness. This year’s theme
promotes ‘Kidney health for everyone
everywhere – from prevention to detection
and equitable access to care.’
In creating awareness on kidney health,
Prof Halim said, “Malaysian Society of
Nephrology is doing our part in improving
the knowledge of general practitioners
but also works hand-in-hand with NGOs to
increase public awareness.
It is vital to have
access to care for
our kidney. This
includes early
screening as well as
seeking treatment
for prevention.”
— Dr Abdul Halim
He said, “Since diabetes is the main
cause of kidney disease in the country,
Malaysians should be wary about what
they eat. Diabetic patients should be
empowered to control their diabetic and
the complications .”
It is vital to have access to care for our
kidneys. This includes early screening as
well as seeking treatment for prevention.
— The Health