Follow-On Biologics: Intellectual Property and Innovation Issues (CRS Report for Congress)
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| Release Date |
Revised Jan. 6, 2010 |
| Report Number |
RL33901 |
| Report Type |
Report |
| Authors |
Wendy H. Schacht, Specialist in Science and Technology Policy; John R. Thomas, Vising Scholar |
| Source Agency |
Congressional Research Service |
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Summary:
Biologics, which are sometimes termed biopharmaceutials or biotechnology drugs, have begun to play an increasingly important role in U.S. health care. Not only are sales of biologics growing rapidly, some experts estimate that in coming years half of all newly approved drugs will result from biotechnology. [â¦] Legislation introduced in the 110th Congress would create an expedited marketing approval pathway for follow-on biologics within the Public Health Service Act. The Access to Life-Saving Medicine Act, introduced as H.R. 1038 and S. 623, would grant the Secretary of Health and Human Service certain discretion to determine, on a case-by-case basis, what studies were necessary to establish comparability. Under these bills, an applicant for a comparable biological product would be allowed optionally to elect to establish 'interchangeability' with the brandname product. The other two bills, H.R. 1956 and S. 1505, instead call for the publication of a number of administrative guidance documents that stipulate the particular data required to file a marketing approval application for a particular category of biologics. Interested parties would then be permitted to file applications for similar biological products within that category. Certain of these bills also address the patent consequences of follow-on generics practice.
