The Hill: On Monday, experts warned during a Capitol Hill discussion hosted by the Congressional Health Care Caucus that "the absence of mandatory clinical trials for biosimilar drugs could compromise their safety and effectiveness." The recently passed health reform law "outlined a pathway for the Food and Drug Administration (FDA) to approve next-generation biopharmaceuticals modeled on original breakthrough drugs. But the provision is vague, the critics say, and leaves FDA with a great deal of leeway to okay those drugs - including the flexibility to decide whether clinical trials are necessary at all" (Mike Lillis, 7/19).
Congressional Daily: "The law allows the FDA to determine that a biosimilar drug is 'interchangeable' with a brand name drug if the treatment is 'expected to produce the same clinical result' as the brand name drug, but the legislation does not exactly define the test for biosimilarity." However, "the FDA is expected to begin holding public meetings later this year to solicit comment on how the process should work. ... But some health policy experts argue that regardless of what approval pathway the FDA establishes, generic drug companies might be better off arguing their products are entirely unique to brand-name drugs, given the long period of exclusivity that brand-name drugs have" (Meghan McCarthy, 7/20).
This information was reprinted from kaiserhealthnews.org with kind permission from the Henry J. Kaiser Family Foundation. You can view the entire Kaiser Daily Health Policy Report, search the archives and sign up for email delivery at kaiserhealthnews.org.
AI
