{
  "abstract": "Biosimilar development for therapeutic proteins (TPs) with limited systemic exposure presents distinct challenges, as the new paradigm based on comparative analytical assessments plus pharmacokinetic similarity without a comparative efficacy study (CES) is inapplicable. Of 19 TPs with limited systemic exposure, 15 are well-characterized, of which 12 have at least one CES-feasible indication. The remaining 3 may require alternative strategies, including pharmacodynamic (PD) biomarker approaches or optimized CES designs, underscoring the need for proactive regulatory engagement.",
  "abstract_shown": true,
  "affiliations": [
    "Therapeutic Biologics Program, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research U.S. Food and Drug Administration Silver Spring Maryland USA",
    "Division of Infectious Disease Pharmacology, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research U.S. Food and Drug Administration Silver Spring Maryland USA",
    "Division of Cardiometabolic and Endocrine Pharmacology, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research U.S. Food and Drug Administration Silver Spring Maryland USA"
  ],
  "article_type": "other",
  "arxiv": null,
  "author_total": 6,
  "authors": [
    {
      "affs": [
        0
      ],
      "name": "Ting Wang",
      "orcid": "0000-0002-0241-0092"
    },
    {
      "affs": [
        1
      ],
      "name": "Jenny Zheng",
      "orcid": "0009-0003-3859-6372"
    },
    {
      "affs": [
        2
      ],
      "name": "Po‐Hung Hsieh",
      "orcid": "0000-0003-1744-4815"
    },
    {
      "affs": [
        0
      ],
      "name": "Anh‐Dung Le"
    },
    {
      "affs": [
        0
      ],
      "name": "Yow‐Ming Wang",
      "orcid": "0000-0002-0663-7358"
    },
    {
      "affs": [
        0
      ],
      "name": "Qin Sun",
      "orcid": "0000-0001-7499-2055"
    }
  ],
  "bibtex": "https://research.draconitic.com/paper/d9axkwar1s1hp.bib",
  "cited_by": 0,
  "doi": "10.1002/cpt.70543",
  "fulltext_url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC13713891/",
  "id": "d9axkwar1s1hp",
  "issns": [
    "0009-9236",
    "1532-6535"
  ],
  "landing_url": "https://doi.org/10.1002/cpt.70543",
  "language": "en",
  "licence": "PDM-1.0",
  "licence_label": "Public domain",
  "licence_source": "journal",
  "licence_url": "https://creativecommons.org/publicdomain/mark/1.0/",
  "metadata_licence": null,
  "native_subjects": [
    [
      "heading",
      "Perspective"
    ],
    [
      "openalex",
      "2403|Biosimilars and Bioanalytical Methods"
    ]
  ],
  "openalex": "W7223902799",
  "pdf_url": "https://onlinelibrary.wiley.com/doi/pdfdirect/10.1002/cpt.70543",
  "pmcid": "PMC13713891",
  "pmid": "42946662",
  "published": "2026-10-27",
  "publisher": null,
  "ris": "https://research.draconitic.com/paper/d9axkwar1s1hp.ris",
  "sources": [
    {
      "first_seen": "2026-11-01T12:21:29Z",
      "native_id": "PMC13713891",
      "source": "pmc",
      "url": "https://doi.org/10.1002/cpt.70543"
    }
  ],
  "subjects": [
    {
      "field": "biology",
      "origin": "openalex:2403|Biosimilars and Bioanalytical Methods",
      "subfield": "immunology"
    }
  ],
  "title": "Biosimilar Development Considerations for Therapeutic Proteins With Limited Systemic Exposure: A Landscape Analysis and Pathway Evaluation",
  "title_text": "Biosimilar Development Considerations for Therapeutic Proteins With Limited Systemic Exposure: A Landscape Analysis and Pathway Evaluation",
  "type": "peer-reviewed",
  "updated_at": "2026-11-01T12:21:29Z",
  "url": "https://research.draconitic.com/paper/d9axkwar1s1hp",
  "venue": "Clinical Pharmacology and Therapeutics",
  "versions": []
}