Drug delivery improvements to enable a flexible care setting for monoclonal antibody medications in oncology - Analogue-based decision framework

Bittner, Beate

doi:10.1080/17425247.2023.2184343

Cited by 3 publications

(2 citation statements)

References 98 publications

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“…This strategy allows for greater flexibility in dosing options, taking into consideration both individual preferences and capabilities and country-specific reimbursement models. The approach enables the harmonization of dosing regimens with combination partners and facilitates the development of fixed-dose combinations tailored to specific indications [ 3 ].…”

Section: Developing Sc Versus IV Formulations For Biotherapeutics—rat...mentioning

confidence: 99%

“…In 2018, despite the existence of prior experience with subcutaneous self-administration of large-volume immunoglobulin products, there was still skepticism regarding the general tolerability and acceptance of high-dose and high-volume mAb administration. Today, this methodology is widely employed across various indications and has become a standard practice [ 3 ]. The first large-volume on-body delivery systems and corresponding treatment management strategies have been implemented to enable convenient administration of such biotherapeutics in the comfort of people's homes.…”

Section: Introductionmentioning

confidence: 99%

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Advancing Subcutaneous Dosing Regimens for Biotherapeutics: Clinical Strategies for Expedited Market Access

Bittner,

Schmidt

2023

BioDrugs

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In recent years, subcutaneous administration of biotherapeutics has made significant progress. The self-administration market for rheumatoid arthritis has witnessed the introduction of additional follow-on biologics, while the first subcutaneous dosing options for monoclonal antibodies have become available for multiple sclerosis. Oncology has also seen advancements with the authorization of high-volume subcutaneous formulations, facilitated by the development of high-concentration formulations and innovative delivery systems. Regulatory and Health Technology Assessment bodies increasingly consider preference data in filing dossiers, particularly in evaluating novel drug delivery methods. The adoption of a pharmacokinetic-based clinical bridging approach has become standard for transitioning from intravenous to subcutaneous administration. Non-inferiority studies with pharmacokinetics as the only primary endpoint have started deviating from traditional randomization schemes, favoring the subcutaneous route and comparing with historical intravenous data. While nonclinical and computational models made progress in predicting safety and immunogenicity for subcutaneously dosed antibodies, clinical trial evidence remains essential due to inter-individual variations and the impact of formulation parameters on anti-drug antibody formation. Ongoing technological advancements and the expanding knowledge base on pharmacokinetic–pharmacodynamic correlation across specialty areas are expected to further accelerate clinical development of subcutaneous biologics.

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Section: Developing Sc Versus IV Formulations For Biotherapeutics—rat...mentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Advancing Subcutaneous Dosing Regimens for Biotherapeutics: Clinical Strategies for Expedited Market Access

Bittner,

Schmidt

2023

BioDrugs

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3D printing technology: A new approach for the fabrication of personalized and customized pharmaceuticals

Ullah

Wahab

Khan

et al. 2023

European Polymer Journal

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Evaluating unmet needs in large-volume subcutaneous drug delivery: U.S. payer perspectives on a novel, large-volume on-body delivery system

Desai,

Kenney,

Pezalla

2024

Current Medical Research and Opinion

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Drug delivery improvements to enable a flexible care setting for monoclonal antibody medications in oncology - Analogue-based decision framework

Cited by 3 publications

References 98 publications

Advancing Subcutaneous Dosing Regimens for Biotherapeutics: Clinical Strategies for Expedited Market Access

Advancing Subcutaneous Dosing Regimens for Biotherapeutics: Clinical Strategies for Expedited Market Access

3D printing technology: A new approach for the fabrication of personalized and customized pharmaceuticals

Evaluating unmet needs in large-volume subcutaneous drug delivery: U.S. payer perspectives on a novel, large-volume on-body delivery system

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