In the debate among lawmakers over generic biotech drugs, the disagreement comes down to this: How many years should makers of the brand-name biologics be protected from generic competition? Too short an exclusivity period will decrease companies’ motivation to innovate, supporters of the branded drug makers say. But biologics are expensive and the longer the exclusivity period, the longer patients have to wait for affordable drugs, say others, including the Federal Trade Commission. This week, the Senate Health, Education, Labor and Pensions Committee will be considering a bill introduced by Sen. Edward Kennedy that proposes 13 ½ years of protection, notes the WSJ . That’s nearly twice as long as the seven years recommended by the White House, and appears to support the industry’s position

of at least 12 years of exclusivity. However, BIO, the biotech industry trade group, points out that the plan would offer protection only to new biologics approved after the passage of the bill. Two other bills introduced earlier in the year — one from Senators Sherrod Brown and Chuck Schumer and the other from Rep. Henry Waxman — propose a five-year period of exclusivity with a possibility of an extension. “Biotechnology start-up involves high risk and high cost, but you can’t give these companies open-ended protection from generics,” Sen. Brown told the WSJ. The generic drug industry trade group says that the seven-year compromise is what is needed. Image: iStockphoto

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When Should Biotech Drugs Face Generic Competition?