Insulins as Drugs or Biologics in the USA: What Difference Does it Make and Why Does it Matter?

被引：0

作者：

Kelly George

Gillian Woollett

机构：

[1] Avalere Health LLC,

[2] FDA Policy,undefined

[3] Avalere Health LLC,undefined

来源：

BioDrugs | 2019年 / 33卷

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摘要：

The status of insulins in the USA is about to change as a regulatory matter. After 23 Mar 2020 they, and other hormone products previously regulated as drugs by the US Food and Drug Administration (FDA), even though biologics in science, will become biologics as a regulatory matter too and will be licensed under the Public Health Service Act. This has a number of ramifications for sponsors, patients, and their physicians.

引用

页码：447 / 451

页数：4

共 7 条

[1]

Dudzinski DM(2005)Reflections on historical, scientific, and legal issues relevant to designing approval pathways for generic versions of recombinant protein-based therapeutics and monoclonal antibodies Food Drug Law J. 60 143-260

[2]

Sandow J(2015)Equivalent recombinant human insulin preparations and their place in therapy Eur Endocrinol. 11 10-16

[3]

Landgraf W(2016)Recombinant human insulins—clinical efficacy and safety in diabetes therapy Eur Endocrinol. 12 12-17

[4]

Becker R(undefined)undefined undefined undefined undefined-undefined

[5]

Seipke G(undefined)undefined undefined undefined undefined-undefined

[6]

Landgraf W(undefined)undefined undefined undefined undefined-undefined

[7]

Sandow J(undefined)undefined undefined undefined undefined-undefined

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