1. Asia‟s aging population and is fuelling Generics demand
Jack Aurora, Chief Scientific Officer of Generic Drugs for Hisun Pharma, speaks to
Pharma IQ Editor Bryan Camoens on the emerging trends of biosimilars and the
legislation that comes with it. He also talks about biosimilars and pharmacovigilance and
the touches on the future of generic drugs and biosimilars.
Bryan Camoens: What are some of the key challenges in marketing and distributing
innovators alongside generics in Asia?
Jack Aurora:
Focus on efficiencies and improved customer services are a few of the key drivers in
marketing and distribution in healthcare industry for both innovators and generics sectors.
With the shift in margin compression, tougher and newer regulatory compliance and
competing demand for capital have urged the desired and well needed focus on core
competencies. In addition, the supply chain management has become more of a
professional competency and necessity involving a strong link and provides a real time
visibility which is key strategic imperative.
With an increase in the number of generics products and competing lower margins,
sponsors are driven to offshore to better manage and improve the competitiveness and
profitability. This added logistics further complicates and make the distribution more
challenging and extremely difficult to manage. All these situations and challenges get
difficult to address and manage due to the high cost, time and internal political struggle.
But at the end of the day, the industry has to come out and face the challenge by proper
outsourcing with sound and effective risk mitigation and management policies.
Bryan Camoens: With the emerging trend of biosimilars, how will the dynamics of
the pharmaceutical market be affected?
Jack Aurora:
Someone has said” The future is already here – it is just not evenly distributed and
visible”. Biosimilars like all other biotech drugs need enormous investment and time to
produce especially when referred to regulated markets in US and Europe. In today‟s
tough and difficult economic environment there are not too many players who can and
are willing to jump into and embrace this challenge.

2. As of now some big players such as Sandoz, Teva, Pfizer, Hospira and Mylan do have
sufficient funds and are not hesitating to invest in this area. With that in mind, the pool of
players in this area will remain small for a considerable span of time, say 10 years or so.
Eventually “Biosimilars” would become as uncontroversial as generic pharmaceuticals
are today. Biosimilars will be particularly popular among cancer and a few of other
critical clinical specialties because of drugs‟ lower clinical trial requirements especially
in US. In this regard, after a decade long debate, biosimilars are finding a reality in the
US through a recent and an important milestone FDA meeting in Nov.2010 to allow drug
makers to weigh in on the regulations, including on such issues as interchangeability
between biosimilars and their reference products.
Even though the first milestone step has been taken successfully, the FDA must develop
the working operational framework to implement the law and the same may take up to 3
years followed by an extensive and well needed review process that will take another 2
years or so and therefore Biosimilars may not appear under this new legislation until
2015 the earliest but at least the clock has started moving. Legal concerns and difficulties
to market these Biosimilars (due to the reason that these are not interchangeable like
generics) will be a few of other challenges to mention over here. With this background
and introduction, it is very difficult to paint the clear picture but it is quite certain that the
pharmaceutical industry will continue to evolve and see tougher and tougher times ahead.
Bryan Camoens What are the key market access barriers for generics within Asia?
Jack Aurora:
The ever changing dynamics of the generics market are driving strategic evolution of
leading players with portfolio management, geographic expansion and alliance networks
determining success and failure. Maintaining breadth of portfolio and low cost supply is
critical for commodity generics players. Therefore, an effective portfolio management is
critical to future success in the generics market. In addition, generic players will have to
deal with competition from within and without.
In addition, one must manage within a world of price controls while keeping an eye on
patent violations, legal protections and expenses incurred. Finally it will be very
important and critical for the organizations to manage product pipeline very carefully and
efficiently with proper risk assessment and management attributes in place.
Bryan Camoens: What are the challenges and difficulties in marketing generic
products in Asia?
Jack Aurora:
Asia‟s rapidly growing aging population and limited purchasing power is fuelling
demand for Generics. As of now 25% of Asian population is above 55 years and this
expanding population will further boost the demand for pharmaceutical drugs, and the
relative affordability of generic pharmaceuticals in comparison to their branded drugs
augments their uptake. Majority of Asian countries has inadequate governmental

3. coverage for health insurance, a majority of the population is shouldering their burden of
healthcare costs. In addition, rising cost of R&D due to increasing legislative
requirements and growing technological sophistications puts a lot of pressure in light of
squeezing down profits due to governmental price controls and competition from outside.
With all this background in place, the environment is becoming more complicated and
uncertain. It is the cumulative outcome of combined political, economic, technological
and social factors. Therefore the need of the hour is to be customer-led rather than being
producer-driven. This will certainly demand innovations in each and every area of
pharmaceuticals starting from development until marketing. In parallel, efficiency,
quality, and flexibility are other key focus areas to concentrate and develop so as to
survive in business.
Bryan Camoens: How do prescribers differentiate among the various generic
options available in the market?
Jack Aurora:
Prescribers are the spokesperson and representatives of the patient, the end user of the
product. Cost and quality image are the key drivers and will certainly remain the critical
in deciding for the preferred option. Recalls from the companies and critical observations
and warning letters from the regulatory bodies around the globe do play a significant role
in their decisions to pick up the appropriate generic.
With that in prospective, the business is getting customer driven and focused on quality
and cost. Bringing in innovations in the product to satisfy the customer ease in handling,
usage and managing the expectations with regard to the quality will become more and
more critical as more players especially in collaboration with multinational and “Big”
players will bring in their products in the market.
Bryan Camoens: How unique is the positioning of generics companies in Asia and
how can they withstand competition from Big Pharma?
Jack Aurora:
Generics business model is a „low price, high volume system and high volume is the
biggest attraction of Asia. Generic companies in Asia are positioned very well and have
visible advantages with regard to productivity and cost structure advantages. With this
advantage the Asian Pharma industry will continue to grow at an accelerated pace by
seizing greater share of the fast growing global generics market.
In addition, the industry is expected to significantly boost its share of the generics market
on the back of its expertise in research and development including process engineering.
The focus should be from selling medicines to managing outcomes. Having said this, the
generic industry should not stop here as the business is very dynamic and generics have
to be always on their toes to explore new ways to bring in innovations and further
improve their R&D cost and productivity. This is because “Big” pharma have not stopped

4. their efforts and are always changing and collaborating with inside and outer players and
partners to be able to respond to the demands from the different stakeholder communities.
Bryan Camoens: Asia's exports - what can companies do to ensure the quality and
safety of generics?
Jack Aurora:
Companies need to be aware of the latest changes in the regulatory world and align
themselves to embrace and accept or even exceed those requirements. Quality
commitment and focus should be a senior management core focus and top priority to
manage and address if required.
The quality culture must percolate down the line and ongoing education, training and
awareness programs must be in place to emphasis the importance and management key
focus. Vendor qualification and vendor management program need to strengthened and
structured to bring in the focus on quality and customer satisfaction. Strong and effective
SOP‟s and other procedures especially related to quality and management are very
important to deliver the right results and thereafter maintaining and improving the image
of the organization.
Strict adherence to the regulatory requirements and any deviation and or non-compliance
must be thoroughly investigated and documented to ensure non-repeat incidence and
stricter compliance in future. Last but not least, the supply chain process and participating
stake holders contributing to the movement of good, funds as well as information in the
supply chain should be coordinated and managed to ensure compliance and safety to the
end customer.
Bryan Camoens: With regards to biosimilars and pharmacovigilance, what are the
key considerations for companies and how can we overcome them?
Jack Aurora:
Pharmacovigilance has an entirely different meaning and scope with regard to biosimilars
as against conventional understanding while dealing with small molecules. This is
because biosimilars cannot be authorized based on the same requirements that apply to
generic medicines.
Despite the fact that the biosimilar and reference drug can show similar efficacy, the
biosimilar may exhibit different safety profile in terms of nature, seriousness or incidence
of adverse reactions. It should be kept in mind that due to their specific characteristics,
pharmacovigilance activities required for biopharmaceuticals might differ from those
required for small molecules In addition, the data from pre-authorization clinical studies
normally are insufficient to identify all potential differences.
Therefore, clinical safety of similar biological products must be monitored closely on an
ongoing basis during the post-approval phase including continued risk–benefit

5. assessment. The risk management plan for biosimilars should focus on heightens the
pharmacovigilance measures, identify immunogenicity risk and implement special post-
marketing surveillance. Pharmacovigilance activities can be either routine or additional
post-authorization safety studies (PASS) activities. During safety assessment,
stakeholders are encouraged to use knowledge obtained with biopharmaceuticals with a
comparable pharmacology. PASS of biopharmaceuticals with a comparable
pharmacology may therefore be used to complement each other.
With the background and seriousness of the implications, the critical onus lies on pharma
companies involved in research and manufacturing of Biosimilars. Since small changes in
the production and purification process might alter the safety profile and therefore
activities to improve traceability of the specific biopharmaceutical responsible for the
ADR should be taken into account.
The manufacturing process and controls must be strictly regulated and controlled. Any
deviations and changes should be properly assessed, authorized and documented in terms
of risk assessment and follow-ups. The detailed and comprehensive risk management
plan and pharmacovigilance programs with its application, including a description of the
potential safety issues should be provided and communicated as required.
Bryan Camoens: How will the generics industry continue to evolve with more
patents expiring in the next few years?
Jack Aurora:
There is a big opportunity knocking at the doors of generic industry but it is not that easy
to grab the golden jackpot. Regulatory requirements and expectations are going up day by
day and at the same time innovator and/or brand companies are getting more and more
vigilant and bringing in strategies to delay the generics introduction in the market.
Even generics (me too) companies will need to demonstrate that their products add value
to the patients. This will be accomplished by bringing in innovations into their functions
and focusing a quality culture from top to bottom of the organization.
Quality by design (QbD) will be another requirement and need of the hour rather than
option. So in nutshell generics industry will have a bright future ahead full of
opportunities but only the players with vigilant eyes to quickly read, understand and
adapt to the changing business dynamics and focus on quality in-built rather than testing
at the end will survive and dominate the pharma market.
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Jack Aurora will be speaking at the Generics & Biosimilars Asia conference for more
details please visit www.genericsbiosimilarsasia.com or drop an email to
enquiry@iqpc.com.sg