FDA gets new tools to speed biosimilar drug approvals—and lower costs
S. 3510 — Biosimilar Inspection Modernization Act of 2025 · Filed by Ted Budd (R-NC) · 1 cosponsor · Introduced Dec 16, 2025 · Referred to committee
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What it does
This bill directs the FDA to modernize how it inspects facilities that manufacture biosimilar drugs (lower-cost versions of expensive biologic medicines). It requires the FDA to hold a public meeting and issue a report on using mutual recognition agreements with foreign regulators to conduct inspections, to increase use of remote inspections, and to develop a strategic plan addressing staffing, communication, and coordination challenges in biosimilar facility oversight.
Why we flagged it
The bill's core function is procedural and regulatory: it modernizes FDA inspection processes for biosimilar drug manufacturers by enabling remote assessments, mutual recognition agreements with foreign regulators, and improved internal FDA coordination. It is not a substantive change to drug approval standards, but rather an efficiency and capacity measure.
What the text implies
- Expanded use of mutual recognition agreements and remote inspections may reduce in-person FDA oversight of biosimilar facilities, potentially lowering detection of manufacturing defects if foreign regulatory standards differ from FDA's.
- Reliance on 'trusted foreign partners' for inspections introduces regulatory arbitrage risk: if foreign regulators have lighter standards, biosimilar quality could suffer without explicit harmonization language.
The full analysis lists 4 implications of this text.
Who stands to gain
biosimilar manufacturers (reduced inspection delays, faster market entry); generic/biosimilar pharmaceutical companies; patients and payers (lower drug costs from faster biosimilar availability)