Draft #2: November 12, 2014
Opening Remarks by YBhg. Dato’ Eisah A Rahman
Senior Director of Pharmacy Services, Ministry of Health
At the 1st National Bio-therapeutics Congress
November 22, 2014
(Salutations)
Good morning. It is my great pleasure and honor to be invited here to speak at the first ever
BIosimilar Scientific Summit to be held in Malaysia, and the region.
It is indeed inspiring to see a diverse group of audience present, consisting of healthcare
providers, representatives from the Ministry of Health, Pharmaceutical Services Division,
the National Pharmaceutical Control Bureau, scientists and other parties as you represent the
foundations of the healthcare system in Malaysia and the world over.
For the first time, we also have in our midst over [add number} world-renown names in the
pharmaceutical and healthcare industry, locally and from abroad.
Ladies and gentlemen
Powerful forces are transforming the healthcare industry today.
Across the globe, people are living longer. However, with the rising cost of healthcare, the
journey towards designing new treatments and cures that best serve the needs of patients,
continues unceasingly.
The growth of biotechnology has brought about the introduction of a new range of innovative
treatments for serious diseases, and to this effect, many lives have been transformed. Currently,
patients have access to more than 155 biotechnology drugs and vaccines, and medical science
is still working to increase that number every day. There are more than 418 biotechnology
medicines in development, covering more than 100 diseases, including 210 medicines for
cancer, 50 for infectious diseases, 44 for autoimmune diseases, and 22 for AIDS/HIV and
related conditions1.
As events of the current environment have demonstrated, biosimilars have become important to
the medical field. The theme for this 1st National Bio-therapeutics Congress – Putting Patients
First, is indeed timely to facilitate dialogue and discussion on the growing importance of
biosimilars and its impact on patient-safety.
1
EuropaBio & Biosimilar Medicines. Factsheet. 2008
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Ladies and Gentlemen,
Malaysia recognises biotechnology as one of the new engines of growth for the national
economy. Under the Biotechnology Transformation Programme as well as the Economic
Transformation Programme, biosimilars has been identified as one of the 10 Entry Point
Projects. While we have these in place, I am convinced that we must strengthen and enhance
our partnerships at an international level; constantly review our capacity building initiatives to
meet targets; and consistently build on niche areas of specialties.
With the future becoming more uncertain, we need to strengthen our public-private partnerships
to bring in the next wave of innovative biosimilars development, supported closely by the
relevant regulatory bodies, including the Ministry of Health. Innovation will play an integral role,
with further exploration on high-impact opportunities. Thus, I believe that regulatory science and
regulation, conducted in a manner acceptable to all, will bring about fruitful partnerships. This is
turn will pave the way for meaningful and lasting innovation for positive patient outcomes.
We must also take time to orchestrate our efforts towards producing high-quality talent to meet
our capacity building initiatives. With more medications needed to treat serious diseases, we
believe more biosimilars of highly complex monoclonal antibodies will enter the market. And
herein lies the challenge - as the industry continues to mature and more complex biosimilars are
introduced, the call for quality talent, deep expertise and experience with well-rounded skills has
become even more demanding.
Ladies and Gentlemen,
While biosimilars have tremendous potential to improve quality of life of patients, it also presents
several challenges that cuts across all aspects of safety, regulatory, legal and economy. To
ensure patients all over the world get effective treatment, it needs access to global markets
based on a single development programme that meets the requirement of regulators
internationally.
On a local level, we have the Guidance Document and Guidelines for Registration of Biosimilars
that was introduced in 2008, governing acts and regulations. These Guidelines were adapted
from the European Medical Agency (EMA), with revisions to suit the Malaysian applications.
Despite increasing alignment in the regulatory requirements for biosimilar, there are still lies
many scientific and practical challenges. I would like to bring to your attention three key areas
which I believe are integral to the development of biosimilars moving forward:
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
Firstly, allowance levels or standards required for Indication Extrapolation
Certain guidelines allows for this, but can standards and regulations be improved to achieve
a certain amount of standardisation? For instance, how many levels of indications should be
pursued? Should extrapolation even be allowed?

Secondly, automatic substitution and interchangeability
Malaysia’s guidelines does not allow for automatic substitution for a biosimilar product while
the decision for interchangeability must be based on science and clinical data. Meanwhile,
there are guidelines from other countries that require biosimilar to have special symbols on
the packaging, in addition to intensive monitoring for safety and efficacy. With this said,
Malaysia has now moved forward and has our own guideline on allowing the usage of
biosimilar products on patients.

And thirdly, biologic qualifiers
Given the increasing use of biosimilars, should the active ingredient of the biosimilar hold the
same International Non-proprietary Name (INN) as the original biologic or otherwise? Or
would this create further confusion? Could safety issues arise from the? How much of this
focus should be on patient education as well as for health practitioners if the same name is
used?
These are just some of the questions that we need to consider. Challenges such as these
requires us to perhaps think and act in new ways. We’re not here to obtain immediate answers
but let’s give it some thought and debate on this today, putting our patient’s safety at the
forefront of all our discussions.
On that note, we are also privileged to have with us at the Summit, Puan Arpah Abas, the
Deputy Director/Head of Biotechnology Section of the National Pharmaceutical Control Bureau
who will later be sharing her insights on the evolving regulatory landscape and the challenges in
evaluating biosimilars.
Ladies and Gentlemen
It is indeed exciting times for the Malaysian healthcare industry as medical science and
transformative biomedical advances promises exciting and evolving scientific opportunities. The
pharmaceutical industry has always strived to push the boundaries of innovation in the research
and development eco-system. For us at the Ministry of Health, our primary objective is public
health protection and always putting patient’s safety first.
Given that high level of complexity involved, transparent and open dialogue with all relevant
stakeholders at Summits such as this is key to not only create a robust regulatory framework
that could address global concerns, but also promote a more patient-centred approach. My wish
is that this Summit will draw valuable opinions and incite fruitful discussions on ways to enhance
the growth of the biosimilar sector for Malaysia.
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To conclude, let me emphasize that collaboration among all of us here is key. We must continue
to build bridges, harness the potential and transform Malaysia into a biotechnology powerhouse.
I am pleased to declare the 1st National Bio-therapeutics Congress – Putting Patients First
officially open. May this Summit inspire discussions and solidify solutions that will spur further
innovation and growth in this field.
On that note, I wish you an engaging and productive Summit.
Thank you.
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