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EPP 3
Leverage Patent Expiry by Pursuing
Generic Opportunities
Over the next ten years, the world’s bestselling
drugs, worth about RM435 billion
in annual sales, are set to go off-patent.
Once the major blockbusters lose their
patent protection, there are immense
opportunities for local pharmaceutical
companies to gain from the substantial
slashes in costs.
Having positioned pharmaceuticals as a
key strategic industry, MoH continues to be
a critical driver to support the private sector
efforts to generate business, particularly
in Organisation of Islamic Countries (OIC).
Similarly, the private sector should increase
its involvement by rationalizing existing
capacity, and increasing investments for
expansions or new operations.
Achievements
On 4 July 2011, the Economic Council
approved the Pharmaceutical Off-Take
Agreement-Government Procurement for
New Local Manufactured Pharmaceuticals.
The scheme allows the Government to
procure locally manufactured products
from qualified manufacturers for a set
period of time. The manufacturers are
required to register their products in
another country before the contract to
supply is extended for another set period
of time. This will be a very important
incentive for new pharmaceutical plants
to expand or invest in producing new local
manufactured products.
On 12 October 2011 , MOH announced
the revision of compulsory service for
pharmacists from three years to one,
with the option to extend service for
an additional year. This allows for the
availability of more pharmacists in the
private sector.
The Prime Minister also announced two
private sector initiatives in 2011:
Project Hovid Objective
Pharmaceutical Excellence
(HOPE)
On 2 November 2010, Hovid and Winthrop
Pharmaceutical (M) Sdn Bhd, a subsidiary
of the Sanofi Aventis Group, entered into
an agreement to develop generic drugs.
Valued at approximately RM5 million for
the first three years, the collaboration
There are immense opportunities for local pharmaceutical companies to gain from the patent expiry cliff
includes dossier development together
with the manufacture and supply of
pharmaceutical drugs.
The first phase of this agreement focusses
on the supply of Metformin 850mg MR for
the treatment of diabetes and the painkiller
Tramadol 100mg SR.
In November 2011, Winthrop Pharmaceuticals
extended its agreement with Hovid for the
production of four new generic medicines
in the areas of allergies, gastrointestinal
disease, epilepsy, neuropathic pain and
diabetes.
Metformin Winthrop 850mg MR
Painkiller Tramadol 100mg SR
Biocon Facility at BioXcell,
Iskandar
On 13 June 2011, Indian pharmaceutical
giant Biocon Limited announced an
investment of RM500 million towards
the establishment of a state-of-theart
manufacturing facility at BioXcell,
Iskandar. The first Biocon factory outside
India, the facility will focus on developing
and manufacturing biopharmaceutical
products, including recombinant proteins,
human insulin and insulin analogues, as
well as other sterile drug products and their
delivery devices. The facility is expected to
be in full operation by 2014.
Photo courtesy of businesswireindia
NKEA: Healthcare EPP 1 – EPP 3
Moving Forward
In 2012, the focus will be to review and
address issues relating to pharmaceutical
patent law and policy in Malaysia. MoH
will continue efforts to optimize utilization
of local bioequivalence facilities. This will
include upgrading local facilities and
introducing incentives to encourage local
manufacturers to opt for these facilities.
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