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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Senate Follow-On Biologics Bill Still Stuck In Evergreen Forest
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.
Senate Biosimilars Bill Readied For Take-Off In Next Congress
Kennedy will enter 111th Congress with a ready-to-go bill after committee officially reports out S. 1695 last week.
Biosimilars Pathway Seen As Part Of Health Care Reform Debate Next Year
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