Review of similar medicines would be streamlined, aiming for faster patient access.
This bill would make it easier for certain similar medicines, called biosimilar biological products, to get approved. It aims to streamline the review process for these products, which could help patients get access to them sooner. Companies that make these medicines would also see a simpler regulatory path.
Today, the Public Health Service Act includes specific rules, Section 351(k)(5)(B) and (C), that guide the review of biosimilar biological products. If this bill passes, Section 351(k)(5)(B) would be removed, and Section 351(k)(5)(C) would be renumbered as Section 351(k)(5)(B), aiming to make the review process for these medicines more streamlined.
S 5059 · 119th Congress · July 21, 2026 · AI Summary by gemini-2.5-flash · 9/10
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