This article is interesting in that it gives insite into what govt's might do if they start to run short of anti virals- many on this site have voiced their opinion that 190m doses/yr will be inadequate - and this certainly adds weight to gsk increasing prod limit again-adding further royalty potential for biota over the comming year.
Tests on generic Tamiflu under way
Local pharmaceutical companies have embarked on clinical tests of their generic version of Tamiflu, health officials said yesterday.
Chong Kun Dang Pharmaceutical Corp. and SK Chemicals have received the green light to conduct a bioequivalence test to prove the therapeutic equivalence of their drug's formulation to that of the original product, according to the Korea Food and Drug Administration.
Two additional drug makers - Kukje Pharm and Daewoong Pharmaceutical - are also waiting for approval to conduct tests, the drug safety watchdog said.
Tamiflu, along with Relenza, is the main antiviral drug known to be effective against the H1N1 flu virus, a subtype of influenza A.
In order to be recognized by the drug agency, a generic drug should be identical or within an acceptable bioequivalent range to the brand name counterpart on its dose, dose strength, safety and method of application.
"Generally, it takes 30 days for the approval procedure of the test. But we shortened the time to around seven days, considering the rapid spread of the new flu," said a KFDA official.
However, sales of the generic Tamiflu produced locally would not be permitted until 2016, which is the expiry date of the patent rights owned by Roche, the drug's original manufacturer.
While struggling to secure a sufficient supply of the antiviral drug, the Korean government had hinted at a possible compulsory action to expire the patent. However, because the Swiss pharmaceutical giant has promised to provide additional supplies, the government has decided against patent expiry action, at least for the time being, health officials said.
"The final decision depends totally on the government," said an official familiar with the issue. "Now that its Tamiflu stockpiles are running out, the drug industry is preparing to offer the drugs as soon as it's necessary."
As of August, the government had stockpiles of Tamiflu for 1.61 million people and Relenza for 340,000. Additional batches for 3 million are also planned to arrive here soon.
According to the government's update on Tuesday, the total number of people in Korea infected with the disease has surpassed the 6,000 mark. In recent weeks, five deaths from the flu have been reported.
