FDA Purple Book — Biologics & Biosimilars API avatar

FDA Purple Book — Biologics & Biosimilars API

Pricing

from $100.00 / 1,000 biologic records

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FDA Purple Book — Biologics & Biosimilars API

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

NexGenData

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9 days ago

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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

6 real rows delivered by FDA Purple Book — Biologics & Biosimilars API — run hy2HHnXVlhfbYPNqC on build 0.0.17

applicantblaNumberproprietaryNameproperNamelicenseTypestrength
Pfizer Inc.761118Abriladaadalimumab-afzb351(k) Interchangeable40MG/0.8ML
Pfizer Inc.761118Abriladaadalimumab-afzb351(k) Interchangeable40MG/0.8ML
Pfizer Inc.761118Abriladaadalimumab-afzb351(k) Interchangeable20MG/0.4ML
Pfizer Inc.761118Abriladaadalimumab-afzb351(k) Interchangeable10MG/0.2ML
Pfizer Inc.761118Abriladaadalimumab-afzb351(k) Interchangeable40MG/0.8ML
Amgen Inc.761024Amjevitaadalimumab-atto351(k) Interchangeable20MG/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

FieldTypeDefaultWhat it does
properNamestring"adalimumab"Active substance / nonproprietary name, contains match (e.g. 'adalimumab').
proprietaryNamestringBrand name, contains match (e.g. 'Humira', 'Hadlima').
applicantstringSponsoring company, contains match.
blaNumberstringExact Biologics License Application number.
referenceProductstringFind biosimilars of this reference biologic (matches reference proper/brand name).
licenseTypearray of string351(a) = reference biologic; 351(k) Biosimilar; 351(k) Interchangeable.
onlyBiosimilarsbooleanfalseReturn only 351(k) products (biosimilars and interchangeables).
exclusivityExpiringAfterstringKeep products whose exclusivity expires on/after this date (YYYY-MM-DD).
exclusivityExpiringBeforestringKeep products whose exclusivity expires on/before this date (YYYY-MM-DD). Useful for near-term biosimilar opportunities.
maxResultsinteger3000Maximum 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

EventPrice (USD)When it is charged
Actor Start (apify-actor-start)$5e-05Charged 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)$0.1Single 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.

More from the NexGenData Healthcare & FDA family:

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 — Applicant
  • blaNumber — Bla Number
  • proprietaryName — Proprietary Name
  • properName — Proper Name
  • licenseType — License Type
  • strength — Strength
  • dosageForm — Dosage Form
  • routeOfAdministration — Route Of Administration
  • productPresentation — Product Presentation
  • marketingStatus — 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.

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.