{
  "source": "FDA Purple Book database download, September 2026 release (purplebook-search-September-data-download.csv)",
  "latest_approval_date_in_file": "2026-09-25",
  "antibody_products": {
    "total": 159,
    "licensed": 150,
    "revoked": 9,
    "by_category": {
      "unconjugated monospecific": 116,
      "antibody-drug conjugate": 15,
      "bispecific": 14,
      "fragment": 6,
      "radioconjugate (diagnostic imaging)": 3,
      "radioconjugate (therapeutic)": 2,
      "mixture": 2,
      "immunotoxin": 1
    },
    "licensed_by_category": {
      "unconjugated monospecific": 112,
      "antibody-drug conjugate": 15,
      "bispecific": 14,
      "fragment": 5,
      "mixture": 2,
      "radioconjugate (diagnostic imaging)": 1,
      "radioconjugate (therapeutic)": 1
    },
    "through_2025": {
      "total": 155,
      "by_category": {
        "unconjugated monospecific": 113,
        "antibody-drug conjugate": 14,
        "bispecific": 14,
        "fragment": 6,
        "radioconjugate (diagnostic imaging)": 3,
        "radioconjugate (therapeutic)": 2,
        "mixture": 2,
        "immunotoxin": 1
      }
    },
    "by_year": {
      "1992": 1,
      "1994": 1,
      "1996": 1,
      "1997": 2,
      "1998": 5,
      "2001": 1,
      "2002": 2,
      "2003": 3,
      "2004": 4,
      "2006": 2,
      "2007": 1,
      "2008": 1,
      "2009": 4,
      "2010": 2,
      "2011": 3,
      "2012": 2,
      "2013": 2,
      "2014": 6,
      "2015": 9,
      "2016": 6,
      "2017": 11,
      "2018": 12,
      "2019": 8,
      "2020": 12,
      "2021": 9,
      "2022": 10,
      "2023": 12,
      "2024": 13,
      "2025": 10,
      "2026": 4
    }
  },
  "antibody_351a_blas": {
    "total": 185,
    "licensed": 173,
    "additional_blas": 26
  },
  "fc_based_proteins": {
    "total": 21,
    "through_2025": 18,
    "cber_clotting_factors": 3,
    "licensed": 20
  },
  "biosimilars": {
    "blas": 67,
    "interchangeable": 42,
    "licensed": 67,
    "reference_antibodies": 14,
    "by_reference": {
      "denosumab": 12,
      "adalimumab": 10,
      "ustekinumab": 10,
      "bevacizumab": 6,
      "trastuzumab": 6,
      "tocilizumab": 5,
      "infliximab": 4,
      "ranibizumab": 4,
      "rituximab": 4,
      "eculizumab": 2,
      "omalizumab": 1,
      "pertuzumab": 1,
      "natalizumab": 1,
      "golimumab": 1
    },
    "through_2025": 62
  }
}