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Follow-on Biologics

Congress is considering legislation that would create a regulatory pathway for the Food and Drug Administration (FDA) to approve “biosimilars,” or “follow-on biologics,” which are lower-cost versions of complex biotechnology drugs—called biologics—that have been developed by pharmaceutical or biotechnology companies. University discoveries are often the starting point for new biologics, with universities licensing their discoveries to companies that conduct the further R&D necessary to produce new products.


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