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During its roundtable discussion titled "Follow-On Biologic (FOB) Drugs: Framework for Competition and Continued Innovation," The Federal Trade Commission (FTC) discussed likely effects, patent issues, and regulatory exclusivity periods concerning FOBs.
Washington, DC (Nov. 21)-During its roundtable discussion titled “Follow-On Biologic (FOB) Drugs: Framework for Competition and Continued Innovation,” The Federal Trade Commission (FTC) discussed likely effects, patent issues, and regulatory exclusivity periods concerning FOBs. The event was one of a two-part workshop to address emerging healthcare competition and consumer issues. Although details of the event are not yet posted, the discussion was open for public comment.
Speaking in favor of FTC’s efforts into the investigation of FOBs, the Generic Pharmaceutical Association (GPhA) released a statement encouraging FTC and its Commissioner Pamela Jones Harbour to look into “a sound balance” between “innovation and competition in any truly workable biogenerics legislation.” GPhA argues that Hatch-Waxman can serve as a “reliable model” for biogenerics as it has for the pharmaceutical industry.
“The mere fact that the FTC is conducting this roundtable demonstrates the growing momentum behind ensuring that consumers have access to safe and affordable biogenerics sooner rather than later,” said GPhA President and CEO Kathleen Jaeger.
“As our elected officials grapple with issues like market exclusivity and patent resolution measures, they must do so recognizing that competition will unleash innovation, while at the same time assuring that affordable lifesaving medicines are available for patients in need.”
Meanwhile, at least one report notes how the strained economy has been particularly difficult for biotechnology innovator companies. According to a Bloomberg report released the same day as the FTC roundtable, funding for biotech firms is at the lowest level in a decade. The amount raised this year by biotechnology companies fell by $9.7 billion through September (54%) compared with the same period last year. According to the report, at least five biotech companies have filed for bankruptcy in the past month alone. Companies are delaying research on new drugs, with firms at highest risk being those with compounds heading toward in-human clinical trials.