Biosimilars pentration in Asia limited to life saving drugsTamotsu Fujino, Director, International Affairs for the Japan Generic MedicinesAssociation, speaks to Bryan Camoens on innovator drugs, cost of biosimilars and the thechallenges and difficulties in marketing generic products in AsiaBryan Camoens: What are some of the key challenges in marketing and distributinginnovators alongside generics in Asia?Tamotsu Fujino: Since innovator drugs are usually expensive, not so many people canafford to buy and use them in most of Asian countries. Differential pricing from otherregions will be required if possible.Some countries regulatory authorities are watching this and the originator companiesshould be careful about differential pricing.Bryan Camoens: With the emerging trend of biosimilars, how will the dynamics ofthe pharmaceutical market be affected?Tamotsu Fujino: Since biosimilars will be also very expensive, the penetration in mostof the Asian countries will be not so much except for life-saving drugs for very seriousdiseases 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 saturatedwith generics, new generic entrants should have very low prices or new indications forunmet needs. In addition, local regulatory authorities may not be so friendly to foreigngeneric applicants. Green field start from registration of drugs is not recommendablechoice for generics as each product provide small sales volume and profit. One has tolook if there is a good cooperation partner or acquisition candidate.Bryan Camoens: What are the challenges and difficulties in marketing genericproducts in Asia?
Tamotsu Fujino: New generic entrants must have a broad range of products withcompetitive prices with the existing products or products with new indications for unmetneeds. Since most of generics do not have any patent protection, they may face sooninvasion of very cheap imitations and counterfeits.Bryan Camoens: How do prescribers differentiate among the various genericoptions available in the market?Tamotsu Fujino: Either company image or brand, if uses of brands are permitted, mustbe established by ads and detail men, etc. Some institutional or statutory or businessincentives should also be given.Bryan Camoens: How unique is the positioning of generics companies in Asia andhow can they withstand competition from Big Pharma?Tamotsu Fujino: Only viable way for small size generic companies is to keep a "leanmanagement” and keep low prices and efficient and light-footed distribution. Since onlyBig Pharma can afford to go for biosimilars and unmet need drugs, which usually need alot of investment.Bryan Camoens: Asias exports - what can companies do to ensure the quality andsafety of generics?Tamotsu Fujino: Small to medium-size generic companies should improve theirproduction facilities and collect information on promising products, more efficientproduction and lower priced high-quality primary materials and strategically they shouldalso seek consolidation among themselves to keep up with the level of minimumcompany size for survival.Bryan Camoens: With regards to biosimilars and pharmacovigilance, what are thekey considerations for companies and how can we overcome them?Tamotsu Fujino: In many countries, introduction of an innovative drug is required tokeep several years of forced pharmacovigilance. Biosimilars usually use differentpathways of production from the original, it is quite natural to be required to keepprolonged forced pharmacovigilance like an innovative drug.Since it is very complicated to prove bioequivalence for biosimilars with the originator, Icannot think of any strategy to avoid the required forced pharmacovigilance.Bryan Camoens: How will the generics industry continue to evolve with morepatents expiring in the next few years?Tamotsu Fujino: Eventually consolidation among generic companies may increase assmall 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 ofthem may be acquired by one of Big Pharmas.Tamotsu Fujino will be speaking at the Generics & Biosimilars Asia conference for moredetails please visit www.genericsbiosimilarsasia.com or drop an email firstname.lastname@example.org