Courtesy: Economic Times Blog |
There
are nearly half a billion diabetes patients in the world. The alarming growth
in the global diabetes population is leading to a huge demand for effective
therapies from pre/early diabetes to late-stage disease. Of the 100 million
people who need insulin globally, however, only ‘one in two’ can manage and
afford costs associated with chronic insulin therapy.
As
a leading insulins producer, Biocon is committed to provide affordable access
to high quality insulins to patients worldwide through our differentiated
portfolio, which includes rh-Insulin as well as basal and rapid-acting insulin
analogs along with delivery devices. Our aim over the next 10 years to provide
our insulin products to ‘one in five’ diabetes patients in need of
insulin-based therapy anywhere in the world.
Already,
our global scale capacities for manufacturing high quality, affordable insulins
have positioned us as the largest Asian insulins player and the fourth largest
producer of insulins in the world, enabling us to address the growing needs of
diabetes patients across the globe. Globally, we are among the Top 3
biosimilars players in rh-insulin and Insulin Glargine in terms of market
share.
Insulin Glargine Launch in Japan
In
the beginning of FY17 we took a small but significant step in our journey to
make a global impact in diabetes management through our affordable biosimilar
insulins when our partner FUJIFILM Pharma launched our biosimilar Insulin
Glargine in Japan. This is the first biosimilar from India and second
biosimilar Glargine to be approved and launched in Japan. Importantly, this is
also Biocon’s first biosimilar approval in a developed country.
Our
product will provide a high quality, yet affordable, world-class long-acting
biosimilar basal Insulin Glargine to the over 7 million people with diabetes in
Japan.
As
Japan has a reputation of very high expectations of product quality and
manufacturing standards, the launch earns us huge credibility and validates our
mission of delivering the highest quality at the lowest cost.
If
fact, it is a testament to our commitment to quality and compliance that our
manufacturing facilities were audited and approved by the Japanese regulatory
agency, PMDA, on their very first inspection visit. It endorsed our strong
R&D capabilities spanning process development, analytical characterization,
and preclinical and clinical development, which were leveraged in submitting a
comprehensive regulatory dossier to the Japanese health authorities.
The
significance of the Japanese approval for Glargine goes beyond Japan as it will
likely open some markets for us that rely on a developed country approval and
provides confidence in terms of approvals in other developed markets.
Insulin Approvals in Malaysia
Our efforts to make our insulins more
widely available also got a shot in the arm in the first quarter of FY17 with Biocon’s
rh-Insulin becoming the first product manufactured at Malaysia to be approved
for commercialization by the Ministry of Health (MoH), Malaysia. Biocon’s
Insulin Glargine was also approved by the MoH, Malaysia. These approvals will
open up commercialization opportunities for the company and will enable us to
address the needs of nearly 3.3 million diabetes patients in Malaysia.
The commercialization of the Malaysian
facility will augment our global scale in insulin production thus helping us
achieve the ‘economies of scale’ needed to provide affordable insulin and
insulin analogs to treat diabetes, which now affects nearly ‘one in 11’ adults
globally. Regulatory filings for several other emerging markets are underway to
enable commercial sales from the Malaysian facility.
Biocon is already recognized as
Asia’s largest Insulin producer and our Malaysia facility will further
strengthen our position as a global player.
The development of Insulin Glargine
partnered with our partner Mylan is also tracking towards regulatory filings in
the developed markets during this fiscal.
To address the diabetes burden in the
US, we are collaborating with Lab PiSA to develop generic rh-Insulin. Biocon
will be responsible for clinical development, regulatory approval and
commercializing the product in the U.S. while PiSA would contract manufacture
the drug product in their facilities in Mexico.
These significant developments at the
beginning of FY17 have positioned us well to achieve our long cherished
objective of providing affordable access to transformative, lifesaving biopharmaceuticals
to patients across the globe.
This piece was first published in the Plain Speak on Economic Times Blog on July 28, 2016
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