1. Biosimilars pentration in Asia limited to life saving drugs
Tamotsu Fujino, Director, International Affairs for the Japan Generic Medicines
Association, speaks to Bryan Camoens on innovator drugs, cost of biosimilars and the the
challenges and difficulties in marketing generic products in Asia
Bryan Camoens: What are some of the key challenges in marketing and distributing
innovators alongside generics in Asia?
Tamotsu Fujino: Since innovator drugs are usually expensive, not so many people can
afford to buy and use them in most of Asian countries. Differential pricing from other
regions will be required if possible.
Some countries' regulatory authorities are watching this and the originator companies
should be careful about differential pricing.
Bryan Camoens: With the emerging trend of biosimilars, how will the dynamics of
the pharmaceutical market be affected?
Tamotsu Fujino: Since biosimilars will be also very expensive, the penetration in most
of the Asian countries will be not so much except for life-saving drugs for very serious
diseases such as various types of cancer, AIDS.
Bryan Camoens: What are the key market access barriers for generics within Asia?
Tamotsu Fujino: Since most of the Asian countries except Japan are already saturated
with generics, new generic entrants should have very low prices or new indications for
unmet needs. In addition, local regulatory authorities may not be so friendly to foreign
generic applicants. Green field start from registration of drugs is not recommendable
choice for generics as each product provide small sales volume and profit. One has to
look if there is a good cooperation partner or acquisition candidate.
Bryan Camoens: What are the challenges and difficulties in marketing generic
products in Asia?

2. Tamotsu Fujino: New generic entrants must have a broad range of products with
competitive prices with the existing products or products with new indications for unmet
needs. Since most of generics do not have any patent protection, they may face soon
invasion of very cheap imitations and counterfeits.
Bryan Camoens: How do prescribers differentiate among the various generic
options available in the market?
Tamotsu Fujino: Either company image or brand, if uses of brands are permitted, must
be established by ads and detail men, etc. Some institutional or statutory or business
incentives should also be given.
Bryan Camoens: How unique is the positioning of generics companies in Asia and
how can they withstand competition from Big Pharma?
Tamotsu Fujino: Only viable way for small size generic companies is to keep a "lean
management” and keep low prices and efficient and light-footed distribution. Since only
Big Pharma can afford to go for biosimilars and unmet need drugs, which usually need a
lot of investment.
Bryan Camoens: Asia's exports - what can companies do to ensure the quality and
safety of generics?
Tamotsu Fujino: Small to medium-size generic companies should improve their
production facilities and collect information on promising products, more efficient
production and lower priced high-quality primary materials and strategically they should
also seek consolidation among themselves to keep up with the level of minimum
company size for survival.
Bryan Camoens: With regards to biosimilars and pharmacovigilance, what are the
key considerations for companies and how can we overcome them?
Tamotsu Fujino: In many countries, introduction of an innovative drug is required to
keep several years of forced pharmacovigilance. Biosimilars usually use different
pathways of production from the original, it is quite natural to be required to keep
prolonged forced pharmacovigilance like an innovative drug.
Since it is very complicated to prove bioequivalence for biosimilars with the originator, I
cannot think of any strategy to avoid the required forced pharmacovigilance.
Bryan Camoens: How will the generics industry continue to evolve with more
patents expiring in the next few years?
Tamotsu Fujino: Eventually consolidation among generic companies may increase as
small size companies cannot very well keep on investing in new generics while the price

3. margins of already marketing products are being reduced to unprofitable level. Some of
them may be acquired by one of Big Pharmas.
Tamotsu Fujino 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