Biosimilar “Interchangeability” Standard Is Double-Edged Sword For Generics
The interchangeability standard for follow-on biologics set out in Senate legislation creates a relatively smooth pathway for generic firms to seek approval of such products, but could also lead to an extended struggle to win acceptance for such products in the marketplace
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Despite moving a bill out of committee last session, the Senate is still wrangling over the issue of whether modifications of existing products should get full exclusivity.
Kennedy will enter 111th Congress with a ready-to-go bill after committee officially reports out S. 1695 last week.
The potential for cost savings from biosimilars is likely to entangle the debate over a pathway for their approval into the discussion on health care reform that will unfold in the next Congress