Elena Holz-Wolff

PEI Str 51-58
Langen, NI 63207, Germany

Last Updated: 09/26/2026

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Found 18 publications

Efficacy, pharmacodynamics, pharmacokinetics, safety, and immunogenicity of Bmab 1000 vs reference denosumab: 78-wk results from a randomized, double-blind, multicenter, parallel-arm Phase 3 trial (DEVOTE) in women with postmenopausal osteoporosis.

Efficacy, pharmacodynamics, pharmacokinetics, safety, and immunogenicity of Bmab 1000 vs reference denosumab: 78-wk results from a randomized, double-blind, multicenter, parallel-arm Phase 3 trial (DEVOTE) in women with postmenopausal osteoporosis.

Journal: JBMR plus

Published: February 20, 2026

Comparative efficacy and safety of biosimilar Bmab 1200 versus reference ustekinumab in moderate-to-severe plaque psoriasis: 52-week findings from the Phase 3 STELLAR-2 trial.

Comparative efficacy and safety of biosimilar Bmab 1200 versus reference ustekinumab in moderate-to-severe plaque psoriasis: 52-week findings from the Phase 3 STELLAR-2 trial.

Journal: Expert opinion on biological therapy

Published: October 16, 2025

Efficacy and safety of the ustekinumab biosimilar, Bmab 1200, versus reference ustekinumab in moderate-to-severe plaque psoriasis: 28‑week results of the randomized, double-blind, Phase 3 STELLAR-2 study.

Efficacy and safety of the ustekinumab biosimilar, Bmab 1200, versus reference ustekinumab in moderate-to-severe plaque psoriasis: 28‑week results of the randomized, double-blind, Phase 3 STELLAR-2 study.

Journal: Expert opinion on biological therapy

Published: July 25, 2025

Analytical Data and Single-Dose PK are Sufficient to Conclude Comparable Immunogenicity for Biosimilars: An Ustekinumab Case Study.

Analytical Data and Single-Dose PK are Sufficient to Conclude Comparable Immunogenicity for Biosimilars: An Ustekinumab Case Study.

Journal: BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy

Published: July 06, 2025

Do the Outcomes of Clinical Efficacy Trials Matter in Regulatory Decision-Making for Biosimilars?

Do the Outcomes of Clinical Efficacy Trials Matter in Regulatory Decision-Making for Biosimilars?

Journal: BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy

Published: September 27, 2023

A Data Driven Approach to Support Tailored Clinical Programs for Biosimilar Monoclonal Antibodies.

A Data Driven Approach to Support Tailored Clinical Programs for Biosimilar Monoclonal Antibodies.

Journal: Clinical pharmacology and therapeutics

Published: August 31, 2022

Regulatory Evaluation of Biosimilars: Refinement of Principles Based on the Scientific Evidence and Clinical Experience.

Regulatory Evaluation of Biosimilars: Refinement of Principles Based on the Scientific Evidence and Clinical Experience.

Journal: BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy

Published: April 13, 2022

WHO informal consultation on revision of guidelines on evaluation of similar biotherapeutic products, virtual meeting, 30 June - 2 July 2021.

WHO informal consultation on revision of guidelines on evaluation of similar biotherapeutic products, virtual meeting, 30 June - 2 July 2021.

Journal: Biologicals : journal of the International Association of Biological Standardization

Published: January 07, 2022

Safety, Immunogenicity and Interchangeability of Biosimilar Monoclonal Antibodies and Fusion Proteins: A Regulatory Perspective.

Safety, Immunogenicity and Interchangeability of Biosimilar Monoclonal Antibodies and Fusion Proteins: A Regulatory Perspective.

Journal: Drugs

Published: August 30, 2021

Identifiability of Biologicals: An Analysis Using EudraVigilance, the European Union's Database of Reports of Suspected Adverse Drug Reactions.

Identifiability of Biologicals: An Analysis Using EudraVigilance, the European Union's Database of Reports of Suspected Adverse Drug Reactions.

Journal: Clinical pharmacology and therapeutics

Published: April 23, 2021

Biosimilars in the European Union: current situation and challenges

Biosimilars in the European Union: current situation and challenges

Journal: Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz

Published: May 19, 2020

Evolution of the EU Biosimilar Framework: Past and Future.

Evolution of the EU Biosimilar Framework: Past and Future.

Journal: BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy

Published: September 22, 2019

Showing 1-12 of 18

Last Updated: 09/26/2026