Answers are grounded in this paper and cite their sources.
In 2010, Congress created an abbreviated application pathway for biosimilars, versions of approved biologics made by different manufacturers. However, as of November 1, 2018, the US Food and Drug Administration (FDA) had approved only 13 biosimilars under this pathway, of which just 6 were available for patients to use. We review the history of US regulation of biologics and identify manufacturing, regulatory, and marketing issues that have limited biosimilar market entry and uptake, concluding with recommendations for reform.
No takes yet. Share an insight, caveat, or question.
Sarpatwari et al. (2018) studied this question.
Synapse has enriched 10 related papers. Consider them for comparative context: