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?

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

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