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Drugs & devicesSource-backed product
FDA Purple Book — licensed biologics + biosimilars
The FDA's record of licensed biologic drugs and their biosimilars, showing which are reference products, which are biosimilar or interchangeable, and their exclusivity dates. 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.
- rows
- 11.9K
- rows
- datasets
- 1
- datasets
- cadence
- quarterly
- cadence
- coverage
- 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.
11.9K rows