Supplement tables for the Interchangeability Designations of FDA-Licensed Biosimilars: A Purple Book Analysis of Timing, Route of Administration, Dosage Form, and Presentation

This record holds the supplementary materials for the article "Interchangeability Designations of FDA-Licensed Biosimilars: A Purple Book Analysis of Timing, Route of Administration, Dosage Form, and Presentation" by Bhasker Sambar, Anil Kumar Dudam, Venkataramana Konda, and Uma Venkata Sai Yasaswini Manne, submitted to Biologics (MDPI). The study surveys all 94 biosimilar Biologics License Applications (BLAs) licensed under section 351(k) by the FDA's Center for Drug Evaluation and Research. It describes which biosimilars are interchangeable, when they were designated, and how this relates to route of administration, dosage form, and presentation. All data come from the FDA Purple Book monthly data file, August 2026 release (data as of 25 August 2026). Results are counts and percentages; no statistical tests were done. Files 1. Supplementary Tables (Excel workbook, seven sheets)Table S1. All 94 biosimilar BLAs, one row per BLA: BLA number, brand name, biosimilar, reference product, applicant, approval date, interchangeability date, months from approval to designation, status, route, dosage form, presentations, and marketing status.Table S2. Status under other ways of counting.Table S3. Days on which FDA designated two or more biosimilars of one reference product.Table S4. BLAs approved before and after FDA's June 2024 draft guidance.Table S5. Data extraction counts.Table S6. Data notes.Table S7. Methods decisions (what was included or excluded). 2. File S1 (CSV)The FDA Purple Book data file, August 2026 release, downloaded from https://purplebooksearch.fda.gov/downloads on 26 September 2026. The file starts with a monthly change report, followed by the full database. Only the full database was used. Source and methodsThe Purple Book is published by the US Food and Drug Administration and is publicly available. The supplementary tables were derived from File S1 by the authors. Presentation-level rows were combined into one record per BLA. The tables were produced with a Python script written with the help of a generative AI tool (Claude, Anthropic), as disclosed in the article. The authors reviewed and verified the output. Contact: Bhasker Sambar, [e-mail] Kumar Dudam, [e-mail]