Therapeutic Biologics Program (TBP)
Who We Are
Therapeutic Biologics Program (TBP) is in the Immediate Office within the Office of Clinical Pharmacology (OCP). TBP consists of scientists with broad clinical pharmacology knowledge and specialized experience in biologics and biosimilars.
What We Do
The TBP team facilitates the development and approval of novel biologics and biosimilars through multiple activities:
- Lead or contribute to policy development and revision;
- Provide consult to review team or participate in review;
- Conduct research to address review issues and knowledge gap;
- Collaborate internally and externally to enhance communication and advance science.
Contact Information
Therapeutic Biologics Program
Office of Clinical Pharmacology
Office of Translational Science
Center for Drug Evaluation and Drug Research
U.S. Food & Drug Administration
Email: therapeuticbiologicsprogram@fda.hhs.gov
Highlighted Publications
- Dosing Strategies and Quantitative Clinical Pharmacology for Bispecific T-Cell Engagers Development in Oncology. Elmeliegy M, Chen J, Dontabhaktuni A, Gaudy A, Kapitanov GI, Li J, Mim SR, Sharma S, Sun Q, Ait-Oudhia S. Clin Pharmacol Ther. 2024 Sep;116(3):637-646. doi: 10.1002/cpt.3361. Epub 2024 Jul 4. PMID: 38962850.
- FDA Guidance Snapshot: Clinical Pharmacology Considerations for Antibody-Drug Conjugates. Sun Q, Ridge S.
- Changing the Drug Development and Therapeutic Paradigm with Biologic Drug Combinations and Bispecifics: How to Choose Between These Two Approaches? Zheng S, Prell R, Sheng J, Wang YM, Hamuro L. Clin Transl Sci. 2022 Sep;15(9):2096-2104. doi: 10.1111/cts.13345. Epub 2022 Jun 11. PMID: 35611545.
- Impact of Organ Impairment on the Pharmacokinetics of Therapeutic Peptides and Proteins. Fletcher EP, Sahre M, Hon YY, Balakrishnan A, Zhou L, Sun Q, Wang J, Maxfield K, Naik R, Huang SM, Wang YC. AAPS J. 2023 May 26;25(4):54. doi: 10.1208/s12248-023-00819-0. PMID: 37231199.
- Consideration for Biologic Product Drug-drug Interactions: A Regulatory Perspective. Schrieber SJ, Pfuma-Fletcher E, Wang X, Wang YC, Sagoo S, Madabushi R, Huang SM, Zineh I. Clin Pharmacol Ther. 2019 Jun;105(6):1332-1334. doi: 10.1002/cpt.1366. Epub 2019 Mar 7. PMID: 30844077.
- FDA Guidance Snapshot: Drug-Drug Interaction Assessment for Therapeutic Proteins. Pfuma-Fletcher E, Sun Q.
- Clinical Pharmacology Approaches to Support Approval of New Routes of Administration for Therapeutic Proteins. Wang YC, Ji P, Hariharan S, Wang J, Okusanya O, AbuAsal B, Zhu H, Madabushi R, Huang SM, Zineh I. Clin Pharmacol Ther. 2024 Mar;115(3):440-451. doi: 10.1002/cpt.3178. Epub 2024 Jan 18. PMID: 38235832.
- Systematic Review of Device Parameters and Design of Studies Bridging Biologic-Device Combination Products Using Prefilled Syringes and Autoinjectors. Hu P, Wang J, Florian J, Shatzer K, Stevens AM, Gertz J, Ji P, Huang SM, Zineh I, Wang YC. AAPS J. 2020 Feb 27;22(2):52. doi: 10.1208/s12248-020-0433-8. PMID: 32107671.
- A Survey of FDA Approved Monoclonal Antibodies and Fc-Fusion Proteins for Manufacturing Changes and Comparability Assessment. Li Z, Du X, Wang YC. Pharm Res. 2024 Jan;41(1):13-27. doi: 10.1007/s11095-023-03627-5. Epub 2023 Nov 1. PMID: 37910341.
- Current Perspectives on Ligand-Binding Assay Practices in the Quantification of Circulating Therapeutic Proteins for Biosimilar Biological Product Development. Thway TM, Wang YM, Booth BP, Maxfield K, Huang SM, Zineh I. AAPS J. 2019 Dec 19;22(1):15. doi: 10.1208/s12248-019-0397-8. PMID: 31858313.
- A Survey of Pharmacokinetic Bioanalytical Methods in Biosimilar Biological License Applications for the Assessment of Target and Antidrug Antibody Effects. Hackel DT, Thway TM, Huang SM, Wang YC. Bioanalysis. 2021 Sep;13(17):1323-1332. doi: 10.4155/bio-2021-0116. Epub 2021 Sep 13. PMID: 34515515.
- Anti-drug Antibody Validation Testing and Reporting Harmonization. Myler H, Pedras-Vasconcelos J, Phillips K, Hottenstein CS, Chamberlain P, et al. AAPS J. 2021 Dec 1;24(1):4. doi: 10.1208/s12248-021-00649-y. PMID: 34853961.
- Pharmacodynamic Biomarkers: Their Role in Biosimilar Product Development. Spotlight on CDER Science (2023).
- Advancing Innovations in Biosimilars. Wang YM, Strauss DG. Clin Pharmacol Ther. 2023 Jan;113(1):11-15. doi: 10.1002/cpt.2782. PMID: 36546543.
- Pharmacodynamic Biomarkers for Biosimilar Development and Approval: A Workshop Summary. Florian J, Sun Q, Schrieber SJ, White R, Shubow S, Johnson-Williams BE, Sheikhy M, Harrison NR, Parker VJ, Wang YM, Strauss DG. Clin Pharmacol Ther. 2023 May;113(5):1030-1035. doi: 10.1002/cpt.2795. Epub 2022 Dec 2. PMID: 36380593.
- Model-Based Approach to Selecting Pegfilgrastim Dose for Pharmacokinetic and Pharmacodynamic Similarity Studies in Biosimilar Development. Li F, Sun Q, Du S, Florian J, Wang Y, Huang SM, Zineh I, Wang YC. Clin Pharmacol Ther. 2023 Jan;113(1):62-70. doi: 10.1002/cpt.2722. Epub 2022 Aug 24. PMID: 36000498.
FDA Guidances Related to Clinical Pharmacology of Biologics and Biosimilars
2024
- Clinical Pharmacology Considerations for Antibody-Drug Conjugates
- Drug Interaction Information in Human Prescription Drug and Biological Product Labeling
2023
2022
- Immunogenicity Information in Human Prescription Therapeutic Protein and Select Drug Product Labeling - Content and Format
- M10 Bioanalytical Method Validation and Study Sample Analysis
- Pharmacokinetic-Based Criteria for Supporting Alternative Dosing Regimens of Programmed Cell Death Receptor-1 (PD-1) or Programmed Cell Death-Ligand 1 (PD-L1) Blocking Antibodies for Treatment of Patients with Cancer
2021
2019
- Bioanalytical Methods Templates
- Bridging for Drug-Device and Biologic-Device Combination Products
- Immunogenicity Testing of Therapeutic Protein Products - Developing and Validating Assays for Anti-Drug Antibody Detection
2014
2024
2023
2021
- Questions and Answers on Biosimilar Development and the Biologics Price Competition and Innovation Act
- New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 3)
2019
- Clinical Immunogenicity Considerations for Biosimilar and Interchangeable Insulin Products
- Considerations in Demonstrating Interchangeability With a Reference Product
2018
2016
Please refer to the FDA guidance search website and the FDA guidance snapshot and podcast website for more information.
Collaboration and Outreach
This workshop explored the current state of the science in the field of therapeutic drug monitoring (TDM) for biologic products and current clinical practice in the United States and Europe.
FDA researchers are investigating the utility of pharmacodynamic, or PD, biomarkers to demonstrate biosimilarity. This research can potentially help developers demonstrate that their proposed product is biosimilar to, or interchangeable with an FDA-approved biological product, and improve the efficiency of biosimilar development.
In this webinar, leading academic clinicians with specialties in several therapeutic areas shared their experience with biosimilars, their perspectives on how to improve the efficiency of biosimilar evaluations, and how to increase biosimilar adoption, including the role of clinical pharmacology.
This virtual public workshop was a forum for regulators, biopharmaceutical developers and academic researchers to discuss the current and future role of pharmacodynamic (PD) biomarkers in improving the efficiency of biosimilar product development and approval.
Additional Resources
- Drugs@FDA
- FDA Guidance Search
- FDA Guidance Snapshot and Podcast
- FDA Biosimilars website
- FDA Purple Book (Lists of Licensed Biological Products)
- Office of Clinical Pharmacology/FDA