Generics of Complex Drugs Must Pass Korea FDA's Bioequivalence Test; Another Positive Development for MNCs
This article was originally published in PharmAsia News
Executive Summary
SEOUL - Korea's Food and Drug Administration will soon require medicines made by Korean generic drug makers to pass the agency's bioequivalence test when producing copies of branded originals with more than two active ingredients, also known as complex drugs
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SEOUL - Korea's Food and Drug Administration will soon require medicines made by Korean generic drug makers to pass the agency's bioequivalence test when producing copies of branded originals with more than two active ingredients, also known as complex drugs. The new rule goes into effect Oct. 27. Currently, bioequivalence testing is required for generics with only one active ingredient. "Because of the short period of time that we [KFDA] have exercised the bioequivalence test since 2002, there are still areas that we should beef up to be in line with EU and U.S. standards," Kim Sun-Young, a KFDA official, told PharmAsia News. "The expanded bioequivalence testing is part of that effort." Bioequivalence measures require pharmacokinetic testing that compares generic versions of medicines to the original products to ascertain whether or not they are "equivalent." These tests are especially important in markets like South Korea, where generic drugs are the main profit drivers for many local pharmaceutical producers. The expanded testing comes at a time when there are growing efficacy complaints over generics produced by South Korean companies in an environment where increasingly complex drugs are being reproduced. Kim Nam-Soo, a KFDA deputy manager, said that bioequivalence testing is being rolled out "to cope with international standards in the U.S., EU and Japan." He said there are not many generics of complex drugs being produced in Korea now, but added that demand for such drugs is expected to increase. One-quarter Of Korean Generics Flunked Bioequivalence Tests KFDA said that one-quarter of generic drugs headed for the market were blocked in 2008 because they failed bioequivalence testing standards. The agency reviewed 505 drugs, but only 75 percent, or 379, were approved. In 2007, only 40 percent of generic applications were approved because most failed to show bioequivalence. Results for 2009 are expected sometime next year. "The KFDA's expanded bioequivalence test is obviously bad news for Korean generic-dependent pharmaceutical companies because I think the KFDA's action is part of the Korean government's overall efforts to clean up and beef up hundreds of generic-dependent local pharmaceutical firms," said Chung Bo-Ra, a healthcare analyst at Daishin Securities. "And, cost-wise, it isn't good news for financially weak local pharmaceutical firms because bioequivalence tests cost money for clinical trials." Asked whether the expanded bioequivalence testing, however, could eventually help local firms sell their generics even outside Korea, Chung said she doesn't expect such an upturn. "I am not sure whether the result of KFDA's bioequivalence test is recognized and accepted by the countries in which Korean pharmaceutical firms are trying to sell their generics," said Chung, while noting that Korea is the main market for local generic makers for now. The Korean government has been using both carrots and sticks in its campaign aimed at making Korean companies more globally competitive. South Korea's state-run health insurance corporation last year moved to sue 104 pharmaceutical companies - mostly local producers of generic drugs - for selling medicines that failed bioequivalence tests (Also see "Korea Moving To Sue 104 Drug Firms, Including Some MNCs, For Selling Substandard Generics" - Scrip, 23 Jun, 2009.). Moreover, last week's passage of long-awaited "anti-rebate laws" that enable courts to punish both contributors and receivers of kickbacks could also hurt local companies because doctors could be more inclined to prescribe branded products rather than risk the perception of having accepted local rebates for generics (Also see "Korea's Anti-Rebate Laws Seen Sparking More Demand For MNC Products" - Scrip, 3 May, 2010.). South Korea's Ministry of Health, Welfare and Family Affairs was also mulling plans to require doctors writing prescriptions to include the drug's generic name and active ingredients (Also see "Korean Health Ministry Seeks Prescriptions Listing Active Pharmaceutical Ingredients: Bad News For Brand Name Drugs" - Scrip, 13 Jul, 2009.). - Peter Chang ([email protected]) |