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Drugs & devicesSource-backed product
FDA Purple Book — licensed biologics + biosimilars
The current FDA Purple Book: 4,667 licensed biologic products, including 469 biosimilars, with reference products, interchangeability and exclusivity dates, plus sparse history snapshots since 2020. The reference for when biosimilar competition can begin.
What Vlada adds: Preserves the publisher data, normalizes schema eras and identifiers, and connects the product to compatible healthcare entities with measured join coverage.
- current rows
- 4.7K
- current rows
- datasets
- 1
- datasets
- cadence
- quarterly
- cadence
- coverage
- current; snapshots 2020-2026
- coverage
Publishers: U.S. Food and Drug Administration
What's inside
Primary dataset
The promoted silver Purple Book: FDA licensed biological products with license_type (351(a) reference biologic vs 351(k) biosimilar / interchangeable), reference-product linkage, and exclusivity dates.
grain: One row per (bla_number, product_number) per snapshot.
4.7K rows