Biosimilars With Foreign Comparator Data Could Open U.S. FDA To Criticism
This article was originally published in PharmAsia News
U.S. FDA’s biosimilars draft guidance documents contained a few surprising provisions, including a willingness to accept comparative data referencing a biologic product that is not approved in the U.S., a Covington and Burling attorney says.
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The agency’s first three draft guidances on biosimilar product development describe how to characterize biosimilar and reference products and extrapolate data on one condition of use to another. FDA says interchangeability is difficult to determine now and will require a switching study.
Agency interactions with sponsors under BsUFA are not dependent upon opening an IND. Sponsors may be able to demonstrate similarity to an FDA-licensed reference product by bridging to foreign clinical data, Associate Director for Biosimilars Leah Christl says.
COVID-19 Vaccines: ACIP’s Allocation Proposal Prioritizes Long-Term Care Residents, Essential Workers
First group to receive vaccine would comprise health care personnel and residents of long-term care facilities; next in line are non-health care essential workers, who would take priority over adults with high-risk medical conditions and those ages 65 years and older, according to the CDC advisory committee’s proposed allocation framework.