Senate Committee on Health to Hold Hearing on Follow-on Biologics
by Aaron F. Barkoff
The U.S. Senate Committee on Health, Education, Labor, & Pensions, chaired by Sen. Edward M. Kennedy (D-MA), is planning to hold a full committee hearing on follow-on biologics this Thursday, March 8, at 10 a.m. eastern time. Live audio and video of the hearing will be available on this page of the committee's website.
Last month, lawmakers in the House and Senate re-introduced legislation to establish an abbreviated pathway for FDA approval of follow-on biologics (sometimes also referred to as "biogenerics"). Since then, reports have indicated that the legislation may be attached to the Prescription Drug User Fee Act, which must be renewed before October 1 of this year. Members of both parties have recently indicated that passage of follow-on biologics legislation is a top priority for the current Congress.
Sales of biologic drugs reached $56 billion in 2005, accounting for 20% of total pharmaceutical sales. Understandably, generic drug makers are anxious to enter this market. In addition, with the annual cost of some biologic drugs surpassing $100,000, state Medicare programs and health insurance companies would like to see generic versions of biologic drugs made available as soon as possible. On the other hand, biologics are far more complex than conventional (i.e., small molecule) drugs. Accordingly, innovator drug companies want to ensure that appropriate safety and efficacy studies are conducted before any follow-on biologics are approved.
Source: OrangeBookBlog.com
RELATED READING:
- BIO web-page on follow-on biologics
- GPhA issue page on follow-on biologics
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The U.S. Senate Committee on Health, Education, Labor, & Pensions, chaired by Sen. Edward M. Kennedy (D-MA), is planning to hold a full committee hearing on follow-on biologics this Thursday, March 8, at 10 a.m. eastern time. Live audio and video of the hearing will be available on this page of the committee's website.
Last month, lawmakers in the House and Senate re-introduced legislation to establish an abbreviated pathway for FDA approval of follow-on biologics (sometimes also referred to as "biogenerics"). Since then, reports have indicated that the legislation may be attached to the Prescription Drug User Fee Act, which must be renewed before October 1 of this year. Members of both parties have recently indicated that passage of follow-on biologics legislation is a top priority for the current Congress.
Sales of biologic drugs reached $56 billion in 2005, accounting for 20% of total pharmaceutical sales. Understandably, generic drug makers are anxious to enter this market. In addition, with the annual cost of some biologic drugs surpassing $100,000, state Medicare programs and health insurance companies would like to see generic versions of biologic drugs made available as soon as possible. On the other hand, biologics are far more complex than conventional (i.e., small molecule) drugs. Accordingly, innovator drug companies want to ensure that appropriate safety and efficacy studies are conducted before any follow-on biologics are approved.
Source: OrangeBookBlog.com
RELATED READING:
- BIO web-page on follow-on biologics
- GPhA issue page on follow-on biologics
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6:47 PM
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