What changed in generic and biosimilar regulation in 2026 — and what to ask your supplier

Two regulatory developments in the first half of 2026 have changed the economics of bringing a product to market, and both are relevant to anyone planning a registration file. Neither is likely to change the fundamentals of a generic file, but both affect the cost, the timeline and the evidence you will be asked to present.

Fewer comparative efficacy studies are expected

The FDA's draft guidance removed comparative efficacy studies as the default expectation for demonstrating biosimilarity, and a subsequent revision allowed wider use of comparators licensed outside the United States in pharmacokinetic studies. The agency's comparator-pharmacokinetics guidance remained in draft through September 2026, with finalisation still pending, and the practical effect is that a pharmacokinetic similarity study may cost materially less — savings of up to around twenty million dollars per programme have been discussed in the market. The European Committee for Medicinal Products for Human Use adopted a corresponding reflection paper in March 2026. The important caveat is that savings are only available to programmes that have not yet completed their clinical package, which means this advantage applies to new filings rather than to products already approved or nearly so.

Approval volumes are running ahead of applications

The FDA approved 689 abbreviated new drug applications and granted 250 tentative approvals in fiscal year 2025, against 600 new application receipts — a difference that underscores how quickly the pipeline is clearing. Analysis of approval outcomes indicates that a substantial majority of applications required more than one review cycle, which makes filing quality a direct determinant of time to market. A draft framework covering fiscal years from 2028 onwards also raises the fee differential for facilities located outside the United States, which is worth factoring into any long-term cost comparison between manufacturing origins. Separately, Section 232 pharmaceutical tariffs currently exclude generic drugs, though the policy is under review.

Four questions to put to a supplier

First, ask which comparators were used in the bioequivalence or comparability work, and whether the study relied on a non-US-licensed comparator. If it did, confirm the acceptability position with your own authority before relying on the data. Second, ask how many review cycles the application went through and what the agency's comments were, since this is the most reliable indicator of how your own file will be handled. Third, ask where the manufacturing site is and whether it has been inspected within the last three years, because a facility fee differential and an inspection history both affect what you should expect to pay and how much confidence the data carries. Fourth, ask which document your authority will accept as the basis for the application: a Certificate of Free Sale, a Certificate of Pharmaceutical Product issued by the manufacturer, or a written statement of conformity — the answer determines what you need to commission and how long it takes.

The part that has not changed

None of this alters the fundamental documentation expectations. Batch release against a registered specification, a Certificate of Analysis issued with each shipment, a current GMP certificate covering your dosage form, and a stability programme long enough for your registration period are still the baseline. What has changed is the route by which some of that supporting evidence is generated and how the cost of generating it is distributed. When a supplier quotes a shorter development timeline, it is worth asking what was actually removed from the package rather than assuming the evidence got stronger.

This article reflects published regulatory reporting and does not constitute legal or regulatory advice. Requirements vary by market and are in active development — always confirm the current position with the authority in your country, and with the agency directly, before relying on any of the above.