ArticleTherapeutic innovation & regulatory science2026
Regulatory Requirements for Interchangeable Biosimilar Designation.
Article in Therapeutic innovation & regulatory science, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
1 citing paper in PubMed.
- Therapeutic Applications of Immunobiologics in Autoimmune and Inflammatory Diseases.Pharmaceutics · 2026Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundIn 2019, the US Food and Drug Administration (FDA) finalized guidance for designating interchangeable biosimilars requiring pre-approval phase III clinical trials to evaluate safety when reference and biosimilar formulations are interchanged. In June 2024, Draft FDA Guidance on interchangeability relaxes FDA approval criteria focusing on analytic rather than clinical findings. This study examines US trends in interchangeable biosimilar approvals between 2019 and 2025, manufacturer strategies, and regulatory timelines.
methodsWe used the FDA Purple Book archive (September 2025) to identify interchangeable biosimilars, associated Biologic License Application (BLA) numbers, manufacturers, reference products, and FDA approval dates. FDA submission dates were obtained from FDA approval letters. We analyzed trends by year, manufacturer, product, and product class to assess patterns in approval timing and strategy.
resultsSince 2020, the FDA has approved 26 interchangeable biosimilars, with 19 approved between January 2024 and September 2025. Six are adalimumab biosimilars. Manufacturers employed two strategies: concurrent submission for interchangeability (17 cases) or delayed pursuit (9 cases). Average approval timelines decreased from 798 days for applications dated in 2020 to 364 days for applications dated in 2024. All interchangeable biosimilars completed pre-approval switching studies.
conclusionsConcurrent interchangeable designation is now the predominant regulatory pathway. The FDA June 2024 Draft Guidance, removing switching studies requirement for interchangeability might cut biosimilar development costs and development timelines. These changes, alongside provider and patient education, could enhance biosimilar uptake and reduce biologic drug costs.
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.