ABSTRACT

Biosimilars Action Plan: Balancing Innovation and Competition   [open pdf - 383KB]

"Congress has given the U.S. Food and Drug Administration (FDA), as part of the agency's mission to promote and protect the public health, responsibility for implementing laws intended to strike a balance between encouraging and rewarding innovation in drug development and facilitating robust and timely market competition. Maintaining this balance between innovation and access requires a mix of statutory and regulatory measures, such as creating incentives for innovation in the form of exclusivity periods; modernizing regulatory requirements to maintain efficient, predictable and science-based pathways for drug review with the aim of reducing the time, uncertainty, and cost of drug development; and supporting a competitive marketplace through the efficient approval of lower-cost generic and biosimilar alternatives."

Publisher:
Date:
2018-07
Copyright:
Public Domain
Retrieved From:
Food and Drug Administration: https://www.fda.gov/
Format:
pdf
Media Type:
application/pdf; video/quicktime
URL:
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