Article

Ethical and human subject burdens of trials conducted to evaluate biosimilars

2021-03-09

Abstract excerpt

<h4>ABSTRACT</h4> <h4>Background/Aims</h4> With a policy goal of introducing price competition into the market for biologic drugs after their period of market monopoly is over (called ‘loss of exclusivity’), policymakers created a pathway for companies to make copies of those treatments and termed them ‘biosimilars’. But unlike generic drugs, biosimilar drug copies must be studied in human trials to assure they ha...

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Literature Corpus work: 2cda4a99-c9d7-506e-bf14-b9945621817c
DOI: 10.1101/2021.03.05.21252938

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