Johann Poetzl

Holzkirchen, BY, Germany

Last Updated: 09/26/2026

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Found 29 publications

From analytical similarity to clinical confidence: how regulatory evolution ensures comparable immunogenicity in streamlined biosimilar development.

From analytical similarity to clinical confidence: how regulatory evolution ensures comparable immunogenicity in streamlined biosimilar development.

Journal: Bioanalysis
Published: August 18, 2026

2025 White Paper on Recent Issues in Bioanalysis: Redosing Patients with AAV Gene Therapy; CRS Immunogenicity Risk; Shedding Assays; NHP Studies Immunogenicity; CMC vs Bioanalytical Assays; Artificial Intelligence-Powered Genomic Pipelines for NGS (PART 3A - Recommendations on Gene, Cell, and Vaccine Therapies Immunogenicity & Technologies; Biotherapeutics & Biosimilars Immunogenicity Assessment & Clinical Relevance PART 3B - Regulatory Agencies' Input on Immunogenicity/Technologies of Biotherapeutics, Gene, Cell & Vaccine Therapies).

2025 White Paper on Recent Issues in Bioanalysis: Redosing Patients with AAV Gene Therapy; CRS Immunogenicity Risk; Shedding Assays; NHP Studies Immunogenicity; CMC vs Bioanalytical Assays; Artificial Intelligence-Powered Genomic Pipelines for NGS (PART 3A - Recommendations on Gene, Cell, and Vaccine Therapies Immunogenicity & Technologies; Biotherapeutics & Biosimilars Immunogenicity Assessment & Clinical Relevance PART 3B - Regulatory Agencies' Input on Immunogenicity/Technologies of Biotherapeutics, Gene, Cell & Vaccine Therapies).

Journal: Bioanalysis
Published: January 06, 2026

Corrigendum to "The Totality of Evidence for SDZ-deno: A Biosimilar to Reference Denosumab" [Clin Ther. 2024;46:916-926].

Corrigendum to "The Totality of Evidence for SDZ-deno: A Biosimilar to Reference Denosumab" [Clin Ther. 2024;46:916-926].

Journal: Clinical therapeutics
Published: August 15, 2025

Substantial Comparability of Singlicate Versus Duplicate Analysis-A Retrospective Evaluation of Clinical Immunogenicity in a Biosimilar PK Study.

Substantial Comparability of Singlicate Versus Duplicate Analysis-A Retrospective Evaluation of Clinical Immunogenicity in a Biosimilar PK Study.

Journal: The AAPS journal
Published: June 26, 2025

Evaluation of Anti-SARS-CoV-2 IgG Responses in a Clinical Study of a Biosimilar Candidate to Denosumab Using Singlicate Analysis.

Evaluation of Anti-SARS-CoV-2 IgG Responses in a Clinical Study of a Biosimilar Candidate to Denosumab Using Singlicate Analysis.

Journal: Drugs in R&D
Published: April 29, 2025

The changes necessary in the assessment of immunogenicity for the development of Biosimilars.

The changes necessary in the assessment of immunogenicity for the development of Biosimilars.

Journal: Bioanalysis
Published: February 04, 2025

2024 White Paper on Recent Issues in Bioanalysis: Evolution of Immunogenicity Assessment beyond ADA/NAb; Regulated Genomic/NGS Assays; Hypersensitivity Reactions; Minimum Noise Reduction; False Positive Range; Modernized Vaccine Approaches; NAb/TAb Correlation (PART 3A - Recommendations on Advanced Strategies for Molecular Assays and Immunogenicity of Gene Therapy, Cell Therapy, Vaccine; Biotherapeutics Immunogenicity Assessment & Clinical Relevance PART 3B - Regulatory Agencies' Input on Immunogenicity/Technologies of Biotherapeutics, Gene, Cell & Vaccine Therapies).

2024 White Paper on Recent Issues in Bioanalysis: Evolution of Immunogenicity Assessment beyond ADA/NAb; Regulated Genomic/NGS Assays; Hypersensitivity Reactions; Minimum Noise Reduction; False Positive Range; Modernized Vaccine Approaches; NAb/TAb Correlation (PART 3A - Recommendations on Advanced Strategies for Molecular Assays and Immunogenicity of Gene Therapy, Cell Therapy, Vaccine; Biotherapeutics Immunogenicity Assessment & Clinical Relevance PART 3B - Regulatory Agencies' Input on Immunogenicity/Technologies of Biotherapeutics, Gene, Cell & Vaccine Therapies).

Journal: Bioanalysis
Published: January 25, 2025

Simultaneous isotyping and semi-quantitation of anti-drug antibodies to an IgG1 biotherapeutic using hybrid LBA-LC-MS/MS.

Simultaneous isotyping and semi-quantitation of anti-drug antibodies to an IgG1 biotherapeutic using hybrid LBA-LC-MS/MS.

Journal: Bioanalysis
Published: December 18, 2024

Comparing anti-drug antibody signal-to-noise ratios to assess immunogenicity and interchangeability in adalimumab biosimilar studies.

Comparing anti-drug antibody signal-to-noise ratios to assess immunogenicity and interchangeability in adalimumab biosimilar studies.

Journal: Expert opinion on biological therapy
Published: November 15, 2024

Introducing the Biosimilar Paradigm to Neurology: The Totality of Evidence for the First Biosimilar Natalizumab.

Introducing the Biosimilar Paradigm to Neurology: The Totality of Evidence for the First Biosimilar Natalizumab.

Journal: BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy
Published: July 02, 2024

The Totality of Evidence for SDZ-deno: A Biosimilar to Reference Denosumab.

The Totality of Evidence for SDZ-deno: A Biosimilar to Reference Denosumab.

Journal: Clinical therapeutics
Published: June 13, 2024

Comparative immunogenicity assessment of biosimilar natalizumab to its reference medicine: a matching immunogenicity profile.

Comparative immunogenicity assessment of biosimilar natalizumab to its reference medicine: a matching immunogenicity profile.

Journal: Frontiers in immunology
Published: April 08, 2024
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Last Updated: 09/26/2026