FDA Purple Book — Biologics & Biosimilars API
Pricing
from $100.00 / 1,000 biologic records
FDA Purple Book — Biologics & Biosimilars API
Search the FDA Purple Book: licensed biologics, biosimilars, and interchangeables with reference-product linkage and exclusivity-expiry dates that signal when biosimilar competition can begin. For biosimilar developers, pharma investors, and IP/regulatory teams.
Pricing
from $100.00 / 1,000 biologic records
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NexGenData
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FDA Purple Book
FDA Purple Book public records — biologics and biosimilars, license type and dosage.
Public regulatory/health data — not medical advice.
📊 Sample Output

applicant | blaNumber | proprietaryName | properName | licenseType | strength |
|---|---|---|---|---|---|
| Pfizer Inc. | 761118 | Abrilada | adalimumab-afzb | 351(k) Interchangeable | 40MG/0.8ML |
| Pfizer Inc. | 761118 | Abrilada | adalimumab-afzb | 351(k) Interchangeable | 40MG/0.8ML |
| Pfizer Inc. | 761118 | Abrilada | adalimumab-afzb | 351(k) Interchangeable | 20MG/0.4ML |
| Pfizer Inc. | 761118 | Abrilada | adalimumab-afzb | 351(k) Interchangeable | 10MG/0.2ML |
| Pfizer Inc. | 761118 | Abrilada | adalimumab-afzb | 351(k) Interchangeable | 40MG/0.8ML |
| Amgen Inc. | 761024 | Amjevita | adalimumab-atto | 351(k) Interchangeable | 20MG/0.4ML |
Real rows from run hy2HHnXVlhfbYPNqC on build 0.0.17 (2026-09-25), unedited apart from masked emails/phones and shortened long text; fields the source does not publish are empty.
⚙️ Sample inputs
This is the Store example input — the same input Apify's automated check runs — so it is proven to return rows on the current build. Paste it into the input form, or send it through the API, CLI or a schedule:
{"properName": "adalimumab"}
🔧 Input reference
| Field | Type | Default | What it does |
|---|---|---|---|
properName | string | "adalimumab" | Active substance / nonproprietary name, contains match (e.g. 'adalimumab'). |
proprietaryName | string | Brand name, contains match (e.g. 'Humira', 'Hadlima'). | |
applicant | string | Sponsoring company, contains match. | |
blaNumber | string | Exact Biologics License Application number. | |
referenceProduct | string | Find biosimilars of this reference biologic (matches reference proper/brand name). | |
licenseType | array of string | 351(a) = reference biologic; 351(k) Biosimilar; 351(k) Interchangeable. | |
onlyBiosimilars | boolean | false | Return only 351(k) products (biosimilars and interchangeables). |
exclusivityExpiringAfter | string | Keep products whose exclusivity expires on/after this date (YYYY-MM-DD). | |
exclusivityExpiringBefore | string | Keep products whose exclusivity expires on/before this date (YYYY-MM-DD). Useful for near-term biosimilar opportunities. | |
maxResults | integer | 3000 | Maximum number of product records to return. |
🧾 JSON sample record
One real record from run hy2HHnXVlhfbYPNqC (emails/phones masked, long text shortened):
{"applicant": "Pfizer Inc.","blaNumber": "761118","proprietaryName": "Abrilada","properName": "adalimumab-afzb","licenseType": "351(k) Interchangeable","strength": "40MG/0.8ML","dosageForm": "Injection","routeOfAdministration": "Subcutaneous","productPresentation": "Autoinjector","marketingStatus": "Rx","licensure": "Licensed","approvalDate": "15-Nov-19","interchangeableApprovalDate": "4-Oct-23","referenceProductProperName": "adalimumab","referenceProductProprietaryName": "Humira","supplementNumber": "","submissionType": "Original","interchangeableSupplementNumber": "7","licenseNumber": "2001","productNumber": "001","center": "CDER","dateOfFirstLicensure": "","exclusivityExpirationDate": "","firstInterchangeableExclusivityExpDate": "","referenceProductExclusivityExpDate": "","orphanExclusivityExpDate": "","patentListProvided": "","isBiosimilar": true,"isInterchangeable": true,"isReferenceProduct": false,"referenceProduct": "adalimumab","sourceFile": "https://www.accessdata.fda.gov/drugsatfda_docs/PurpleBook/2026/purplebook-search-August-data-download.csv"}
💰 Pricing
| Event | Price (USD) | When it is charged |
|---|---|---|
Actor Start (apify-actor-start) | $5e-05 | Charged when the Actor starts running. Number of events charged depends on Actor memory (one event per GB, minimum one event). |
Biologic record (apify-default-dataset-item) | $0.1 | Single result in the default dataset. |
Pay-per-event: you pay only for what the run delivers. A run that delivers nothing bills no result events (only the actor-start event, when the actor defines one). Example: a run that delivers 100 results costs 100 × $0.1 = $10.00 plus the start fee.
🔗 Related Actors
More from the NexGenData Healthcare & FDA family:
- FDA Drug Shortages Monitor — Current & Resolved API
- FDA Orange Book — Drug Patent & Exclusivity API
- FDA Pharma Pipeline Tracker — Milestone Data API
- FDA Recall Monitor — Drug & Device Safety Alerts
- FDA Warning Letters & 483 Inspections API
- Medical Device Records — FDA 510(k) & PMA API
15 more in this family on the NexGenData Store page.
📊 What you get
Clean JSON, one record per record (full output has 32 fields):
applicant— ApplicantblaNumber— Bla NumberproprietaryName— Proprietary NameproperName— Proper NamelicenseType— License Typestrength— StrengthdosageForm— Dosage FormrouteOfAdministration— Route Of AdministrationproductPresentation— Product PresentationmarketingStatus— Marketing Status
Pricing: $0.100 per record (Pay-Per-Event) — about 10 records per $1.
🤖 Use with AI agents
Point Claude, the OpenAI Agents SDK, an n8n flow or any MCP-aware client at it and pull official records on demand.
Agentic payments (x402): Supports agentic payment via x402 — agents can call this actor with USDC, no API key required.
🔗 Related regulatory actors
FDA & public-health records family:
OpenFDA Drug · Drug Approvals · Drug Shortages · Warning Letters/483 · Pharma Pipeline · Adverse Events · Medical Devices
Product-safety recalls: NHTSA Recalls · NHTSA Defects · NHTSA Safety · CPSC Recalls
Agent front door — Healthcare & FDA MCP: Healthcare & FDA MCP
Public official records and enforcement data, assembled for research and monitoring.