Biosimilars Research: Awards

The bioassay initiative: enhanced biosimilar testing capabilitiesOPQ/OPQRMay 20232-3 yearsResearch Priority C: Define best-practices for assessing and reporting quality attributesEnhancing CDER bioassay capabilities to additional attributes to provide definition, standardization, and harmonization of expectations for assessing and reporting CQAs, while reducing inconsistencies and unnecessary testingImpact 1: Increase reliance on analytical data in a demonstration of biosimilarity 2025 Annual Report 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/OPQRMay 20232 yearsResearch Priority B: Explore how modernization of analytical technologies could better and/or more efficiently detect relevant quality attributesDevelop 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 drugsImpact 1: Increase reliance on analytical data in a demonstration of biosimilarity 2025 Annual Report 2024 Annual Report Develop acceptance parameters and standards for the Innate Immune Response Modulating Impurities (IIRMI) assays in the Biosimilar spaceOPQ/OPQRApril 20233 yearsResearch 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 biosimilarsImpact 2: Develop alternatives to and/or reduce the size of studies involving human subjects 2025 Annual Report 2024 Annual Report One-Pot Glycan - a chemoenzymatic method for simultaneous profiling and comparison of N- and O-glycansOPQ/OPQRApril 20232-3 yearsResearch 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 formatImpact 1: Increase reliance on analytical data in a demonstration of biosimilarity 2025 Annual Report 2024 Annual Report Model development and verification to evaluate minimum stability data required for biosimilar submissionsOPQ/OPQRSeptember 20233 yearsResearch Priority B: Characterize relationships between product quality attributes with clinical outcomesDetermine the minimum amount of stability data required to accurately predict long term stability and support biosimilar product’s shelf-lifeImpact 1: Increase reliance on analytical data in a demonstration of biosimilarity 2025 Annual Report 2024 Annual Report Landscape Assessment of Biosimilar SubmissionsOTS/OCP/DARSMay 20231 yearResearch Priority A: Characterize relationships between product quality attributes with clinical outcomesConduct 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 dataImpact 1: Increase reliance on analytical data in a demonstration of biosimilarity2024 Annual ReportAddressing fundamental issues for in vitro immunogenicity testingOTS/OCP/DARSMay 20231 yearResearch 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 productsImpact 2: Develop alternatives to and/or reduce the size of studies involving human subjects 2025 Annual Report 2024 Annual Report Validation of a non-clinical immunogenicity modelOTS/OCP/DARSApril 20231 yearResearch 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 modelsImpact 2: Develop alternatives to and/or reduce the size of studies involving human subjects 2025 Annual Report 2024 Annual Report Production & optimization of humanized miceOTS/OCP/DARSSeptember 20231 yearResearch 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 modelsImpact 2: Develop alternatives to and/or reduce the size of studies involving human subjects 2025 Annual Report 2024 Annual Report Critical Factors for Standardization and Accuracy of PK Assays of PEGylated Biosimilars OTS/OCP/DARSSeptember 20231 year Research Priority E: Define development approaches that will increase feasibility and/ or likelihood of successProvide 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​ 2025 Annual Report 2024 Annual Report Translating Clinical Pharmacology Biosimilar Research Findings into Best Practices for Industry and FDA Review StaffOTS/OCP/DARSSeptember 20231 yearResearch Priority E: Define development approaches that will increase feasibility and/ or likelihood of successCloseout of bioanalytical and omics related project activities from the ‘Pharmacodynamic Biomarkers for Biosimilar Approval’ projectImpact 2: Develop alternatives to and/or reduce the size of studies involving human subjects2024 Annual ReportEvidence-based approach to the design of clinical pharmacology studiesOTS/OCPSeptember 20232 yearsResearch Priority E: Define development approaches that will increase feasibility and/ or likelihood of successIncrease the efficiency of biosimilar development programs by leveraging clinical pharmacology studiesImpact 2: Develop alternatives to and/or reduce the size of studies involving human subjects​ 2025 Annual Report 2024 Annual Report Assessment of Immunogenicity in Biosimilars a Systematic ReviewOND/OTBBOctober 20252 yearsResearch Priority A: Characterize relationships between product quality attributes with clinical outcomesTo 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 hypersensitivityImpact 1: Increase reliance on analytical data in a demonstration of biosimilarityThe 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 etanerceptU.S. PHARMACOPEIAAugust 20222-3 yearsResearch Priority B: Explore how modernization of analytical technologies could better and/or more efficiently detect relevant quality attributesTo 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/EDUCAugust 20222-3 yearsResearch Priority C: Define best-practices for assessing and reporting quality attributesTo develop a platform for reliable characterization and evaluation of comparability of biosimilar drug products in lyophilized and liquid formulationsImpact 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 ARBORAugust 20222-3 yearsResearch Priority C: Define best-practices for assessing and reporting quality attributesTo 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 ISPRI-HCP: CHO protein impurity immunogenicity risk prediction for improving biosimilar product development and assessing product interchangeability​EPIVAX, INC.August 20222-3 yearsResearch 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 interchangeabilityImpact 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 20232-3 yearsResearch 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 2025 Annual Report 2024 Annual Report