The Seven-Year Itch in Biologics Exclusivity

Patricia Van Arnum PharmTech editor In the debate over establishing a regulatory pathway for biologics, the White House recommended this week to limit data exclusivity for biologics to seven years, according to a Reuters report. Reuters reported that the Office of Management and Budget Director Peter Orszag and Nancy-Ann DeParle, director of the White House Health Reform Office, sent a letter to Representative Henry Waxman (D-CA), chair of the House Energy and Commerce Committee, whose committee is considering biosimilar legislation, stating that seven years “strikes the appropriate balance between innovation and competition.” As would be expected, supporters of limiting exclusivity such as the Generic Pharmaceutical Association (GPhA) applauded the proposal while the Biotechnology Industry Organization (BIO) raised concerns. Read more »

What is Fair for Drug Exclusivity?

Patricia Van Arnum PharmTech editorThe debate over biosimilars was ratcheted up this week as members of Congress and industry responded to a Federal Trade Commission (FTC) report that examined the impact of possible incentives to promote competition for follow-on biologics (FOB). At the heart of the debate is the length of time for data exclusivity for biopharmaceuticals, with certain key members of Congress seeking reduced times and industry seeking to maintain at least the status quo. The debate raises questions not only on how to proceed in developing a regulatory pathway for biosimilars, but also addresses the larger issue of how measures may hinder or facilitate drug innovation. Read more »

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