Congressional Budget Office Cost Estimate

essay writers paper writingsS. 1695
Biologics Price Competition and Innovation Act of 2007
As ordered reported by the Senate Committee on Health, Education, Labor, and Pensions
on June 27, 2007

Download the full Congressional Budget Office Cost Estimate here (PDF)

SUMMARY

S. 1695 would establish an abbreviated regulatory procedure for licensing biological drugs by the Food and Drug Administration (FDA) that meet certain requirements and are highlysimilar to or interchangeable with products originally licensed to innovator companies under the Public Health Service Act (PHSA). (Biological drugs are products derived from living organisms.) Savings to public and private purchasers of biologics would result from the availability of these lower-priced versions that would be approved by FDA for marketing under the bill. Such competing products are commonly referred to as “follow-on biologics
(FOBs),” “biosimilars,” or “biogenerics.” research paper writer essay help