Lilly and EVA Pharma announce regulatory approval and
release of locally
manufactured insulin in
Egypt
(CAIRO) - The Egyptian
Drug Authority approved the
insulin glargine injection
manufactured by
EVA Pharma through a
collaboration with Eli Lilly and Company
(NYSE: LLY). Launched in
2022, the collaboration aims
to deliver a sustainable
supply of high-quality,
affordable human and analog
insulin to at least one
million people annually
living with type 1 and type
2 diabetes in low- to
middle-income countries
(LMICs), most of which are
in Africa.
This
marks the first regulatory
approval of EVA Pharma’s
insulin drug products,
following Lilly and EVA
Pharma’s collaboration
announcement in December
2022. Under this agreement,
Lilly has been supplying its
active pharmaceutical
ingredient (API) for insulin
to EVA Pharma at a
significantly reduced price
and providing pro-bono
technology transfer to
enable EVA Pharma to
formulate, fill, and finish
insulin vials and
cartridges.
Less than
two years after the initial
announcement, EVA Pharma has
completed a new biologics
manufacturing facility,
finalized insulin
formulations and stability
testing processes, engaged
with the local regulatory
authorities to obtain
approval for the insulin
glargine injection, and
released the first batch of
the locally manufactured
insulin drug product.
EVA Pharma’s human
insulin injection was also
submitted for local
regulatory approval. Lilly
and EVA Pharma continue
working with the World
Health Organization (WHO) to
secure WHO pre-qualification
for the locally manufactured
human insulin injection. The
WHO pre-qualification will
further ensure that
medicines manufactured by
EVA Pharma meet the
high-quality standards set
by WHO.
“For more
than a century, Lilly has
been at the forefront of
diabetes care, offering
innovative solutions that
make life better for people
around the world,” said Ilya
Yuffa, executive vice
president and president of
Lilly International. “Our
collaboration with EVA
Pharma furthers our
commitment to providing
sustainable and accessible
medicines worldwide. We will
continue to work with global
health systems and industry
stakeholders to address
systemic barriers to
healthcare and expand
equitable, affordable access
to our medicines to
transform more people’s
lives.”
“Localizing
essential medicines is the
key to driving equitable
access to healthcare,” said
Riad Armanious, CEO of EVA
Pharma. “It takes bold
collaboration, cutting-edge
innovation, and tech-driven
manufacturing to turn this
vision into reality. Our
collaboration with Lilly
shows what’s possible when
we push boundaries together.
This is just the
beginning—we’re on track to
impact over a million lives
annually across 56
countries, making a real
difference for people living
with diabetes.”
This
collaboration is part of the
Lilly 30x30 initiative,
which aims to improve access
to quality health care for
30 million people living in
resource-limited settings
annually by 2030.
Most recently, Lilly and EVA
Pharma expanded their
collaboration, announcing
that Lilly will license
certain
baricitinib
manufacturing know-how to
enable EVA Pharma to
manufacture and supply the
treatment for various
immunological diseases
across 56 low- to
middle-income countries in
Africa.
