{
  "node_id": "fda-biosimilar-pathway-351k-biologics-competition-act",
  "title": "Biologics Price Competition and Innovation Act of 2009",
  "domain": "Pharmaceuticals & Life Sciences",
  "version": "1.0.1",
  "last_updated": "2026-04-30",
  "bluf": "The FDA 351(k) biosimilar pathway requires that an applicant demonstrate biosimilarity to a reference product…",
  "paywall": {
    "status": "LOCKED",
    "unlock_cost_usd": "0.01",
    "skyfire_id": "41779894-ece2-4163-9761-b3b1b76e19b0"
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  "crosswalks": {
    "_available_keys": [
      "nist_framework",
      "iso_standard",
      "industry_mapping",
      "ai_overlay_2026"
    ],
    "_note": "Full crosswalk values included in vault response"
  },
  "primary_citations_count": 5,
  "workflow_steps_count": 10,
  "schema_fields_count": 6,
  "citation_preview": [
    "Public Health Service Act, Section 351(k) - Licensure of Biological Products",
    "21 CFR 601.2 - Applications for Biological Products"
  ]
}