| The bioassay initiative: enhanced biosimilar testing capabilities |
OPQ/OPQR |
May 2023 |
2-3 years |
Research Priority C: Define best-practices for assessing and reporting quality attributes |
Enhancing CDER bioassay capabilities to additional attributes to provide definition, standardization, and harmonization of expectations for assessing and reporting CQAs, while reducing inconsistencies and unnecessary testing |
Impact 1: Increase reliance on analytical data in a demonstration of biosimilarity |
2024 Annual Report |
| Establishment of a Feasible Method to Quantify Glycoforms of Human IgG1 mAb Drugs and their Biosimilars in Culture Media as a Component of Process Analytic Technology |
OPQ/OPQR |
May 2023 |
2 years |
Research Priority B: Explore how modernization of analytical technologies could better and/or more efficiently detect relevant quality attributes |
Develop mouse monoclonal antibodies against human non-glycosylated and glycosylated IgG1, and establish a Biolayer Interferometry (BLI) method to quantify the major glycoforms of human IgG1 mAb drugs |
Impact 1: Increase reliance on analytical data in a demonstration of biosimilarity |
2024 Annual Report |
| Develop acceptance parameters and standards for the Innate Immune Response Modulating Impurities (IIRMI) assays in the Biosimilar space |
OPQ/OPQR |
April 2023 |
3 years |
Research Priority D: Develop alternatives to comparative clinical immunogenicity assessment(s) |
Develop in vitro assays that can be used to reduce/replace clinical trials to assess immunogenicity risk of biosimilars |
Impact 2: Develop alternatives to and/or reduce the size of studies involving human subjects |
2024 Annual Report |
| One-Pot Glycan – a chemoenzymatic method for simultaneous profiling and comparison of N- and O-glycans |
OPQ/OPQR |
April 2023 |
2-3 years |
Research Priority B: Explore how modernization of analytical technologies could better and/or more efficiently detect relevant quality attributes |
Establish and validate a chemoenzymatic method for simultaneous profiling and comparison N-and O-glycans from purified proteins and protein drugs in a One-Pot format |
Impact 1: Increase reliance on analytical data in a demonstration of biosimilarity |
2024 Annual Report |
| Model development and verification to evaluate minimum stability data required for biosimilar submissions |
OPQ/OPQR |
September 2023 |
3 years |
Research Priority B: Characterize relationships between product quality attributes with clinical outcomes |
Determine the minimum amount of stability data required to accurately predict long term stability and support biosimilar product’s shelf-life |
Impact 1: Increase reliance on analytical data in a demonstration of biosimilarity |
2024 Annual Report |
| Landscape Assessment of Biosimilar Submissions |
OTS/OCP/DARS |
May 2023 |
1 year |
Research Priority A: Characterize relationships between product quality attributes with clinical outcomes |
Conduct a landscape analysis to determine how FDA can answer questions about whether differences in analytical assessments in biosimilar development programs do or do not corelate with clinical data |
Impact 1: Increase reliance on analytical data in a demonstration of biosimilarity |
2024 Annual Report |
| Addressing fundamental issues for in vitro immunogenicity testing |
OTS/OCP/DARS |
May 2023 |
1 year |
Research Priority D: Develop alternatives to comparative clinical immunogenicity assessment(s) |
Validate methods for in vitro immunogenicity testing that could be used by industry to reduce/eliminate the need for clinical trials assessing immunogenicity for biosimilar drug products |
Impact 2: Develop alternatives to and/or reduce the size of studies involving human subjects |
2024 Annual Report |
| Validation of a non-clinical immunogenicity model |
OTS/OCP/DARS |
April 2023 |
1 year |
Research Priority D: Develop alternatives to comparative clinical immunogenicity assessment(s) |
Evaluate the ability of humanized mice to serve as a non-clinical immunogenicity model by evaluating several biological drug products (with clinically moderate to high immunogenicity) alone or in combination in the two most commonly used humanized mouse models |
Impact 2: Develop alternatives to and/or reduce the size of studies involving human subjects |
2024 Annual Report |
| Production & optimization of humanized mice |
OTS/OCP/DARS |
September 2023 |
1 year |
Research Priority D: Develop alternatives to comparative clinical immunogenicity assessment(s) |
Use an established protocol for producing immune humanized mice to generate a cohort for answering regulatory questions related to pharmacokinetics, pharmacodynamics, immunogenicity and adverse events that have not been successfully addressed with other nonclinical models |
Impact 2: Develop alternatives to and/or reduce the size of studies involving human subjects |
2024 Annual Report |
| Critical Factors for Standardization and Accuracy of PK Assays of PEGylated Biosimilars |
OTS/OCP/DARS |
September 2023 |
1 year |
Research Priority E: Define development approaches that will increase feasibility and/ or likelihood of success |
Provide guidance/best practices to industry for evaluating pharmacokinetics (PK) associated with biosimilars that are conjugated to polyethylene glycol (PEG) |
Impact 2: Develop alternatives to and/or reduce the size of studies involving human subjects |
2024 Annual Report |
| Translating Clinical Pharmacology Biosimilar Research Findings into Best Practices for Industry and FDA Review Staff |
OTS/OCP/DARS |
September 2023 |
1 year |
Research Priority E: Define development approaches that will increase feasibility and/ or likelihood of success |
Closeout of bioanalytical and omics related project activities from the ‘Pharmacodynamic Biomarkers for Biosimilar Approval’ project |
Impact 2: Develop alternatives to and/or reduce the size of studies involving human subjects |
2024 Annual Report |
| Evidence-based approach to the design of clinical pharmacology studies |
OTS/OCP |
September 2023 |
2 years |
Research Priority E: Define development approaches that will increase feasibility and/ or likelihood of success |
Increase the efficiency of biosimilar development programs by leveraging clinical pharmacology studies |
Impact 2: Develop alternatives to and/or reduce the size of studies involving human subjects |
2024 Annual Report |
| Assessment of Immunogenicity in Biosimilars a Systematic Review |
OND/OTBB |
October 2025 |
2 years |
Research Priority A: Characterize relationships between product quality attributes with clinical outcomes |
To examine immunogenicity data reviewed by the FDA as included in submissions for approved biosimilars and the corresponding pharmacokinetics (PK) and safety data in a definitive manner using a PRISMA based Systematic Review to determine if associations exist antidrug antibody status and clinical safety events such as hypersensitivity |
Impact 1: Increase reliance on analytical data in a demonstration of biosimilarity |
The annual report for this project will be shared once available. |
| Assessment of the performance of MAM vs conventional QC methods for evaluation of Product Quality Attributes of adalimumab and etanercept |
U.S. PHARMACOPEIA |
August 2022 |
2-3 years |
Research Priority B: Explore how modernization of analytical technologies could better and/or more efficiently detect relevant quality attributes |
To assess the performance of the MS-based MAM versus conventional QC methods to identify changes in PQAs upon forced degradation and to correlate changes in those PQAs with bioactivity, binding affinity, and structure. |
Impact 1: Increase reliance on analytical data in a demonstration of biosimilarity |
2023 Annual Report
2024 Annual Report
|
| Platform for reliable characterization and evaluation of comparability of biosimilar drug products in lyophilized and liquid formulations |
NATIONAL INSTITUTE FOR PHARM TECH/EDUC |
August 2022 |
2-3 years |
Research Priority C: Define best-practices for assessing and reporting quality attributes |
To develop a platform for reliable characterization and evaluation of comparability of biosimilar drug products in lyophilized and liquid formulations |
Impact 1: Increase reliance on analytical data in a demonstration of biosimilarity |
2023 Annual Report
2024 Annual Report
|
| Systematic Analytical Characterization of Innovator and Biosimilar Products with the Focus on Post-translational Modifications |
UNIVERSITY OF MICHIGAN AT ANN ARBOR |
August 2022 |
2-3 years |
Research Priority C: Define best-practices for assessing and reporting quality attributes |
To develop novel methodologies to evaluate structural similarities and differences between innovator and multiple biosimilar products and apply them across different protein drug classes. The proposed work will establish the correlation between post-translation modification differences, receptor binding, antibody dependent cellular cytotoxicity,
aggregation propensity, immunogenicity and clinical efficacy to aid approvals of biosimilar and interchangeable protein products. |
Impact 1: Increase reliance on analytical data in a demonstration of biosimilarity |
2023 Annual Report
2024 Annual Report
|
| Improving the Efficiency of Regulatory Decisions for Biosimilars and Interchangeable Biosimilars by Leveraging Real-World Data |
ACADEMY OF MANAGED CARE PHARMACY, INC. |
August 2022 |
2-3 years |
Research Priority D: Develop alternatives to comparative clinical immunogenicity assessment(s) |
To assess feasibility and fitness for use of real-world data (RWD) to inform FDA regulatory decisions, using switching studies for biosimilar interchangeability as a test case, and to provide recommendations for overcoming challenges and strategies for applying non-US RWD in a US regulatory context. |
Impact 2: Develop alternatives to and/or reduce the size of studies involving human subjects |
2023 Annual Report
2024 Annual Report
|
| ISPRI-HCP: CHO protein impurity immunogenicity risk prediction for improving biosimilar product development and assessing product interchangeability |
EPIVAX, INC. |
August 2022 |
2-3 years |
Research Priority D: Develop alternatives to comparative clinical immunogenicity assessment(s) |
To improve the ISPRI-HCP immunogenicity risk prediction model for biosimilar product development and assessing product interchangeability |
Impact 2: Develop alternatives to and/or reduce the size of studies involving human subjects |
2023 Annual Report
2024 Annual Report
|
| Bridging the Gap: Using Foreign Real-World Data to Inform Interchangeable Biosimilar Approvals |
ACADEMY OF MANAGED CARE PHARMACY, INC. |
September 2023 |
2-3 years |
Research Priority D: Develop alternatives to comparative clinical immunogenicity assessment(s) |
To support research projects that enhance biosimilar and interchangeable biological product development and regulatory science. |
Impact 2: Develop alternatives to and/or reduce the size of studies involving human subjects |
2024 Annual Report |
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