Customer-centric product presentations for monoclonal antibodies

Bittner, Beate

doi:10.1186/s41120-022-00069-y

Cited by 4 publications

(1 citation statement)

References 181 publications

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“…In 2018, the SC injectable market for MS primarily consisted of interferon treatments, available in diverse presentations like prefilled syringes, pens, autoinjectors, and vials for at-home and self-administration. During that period, all authorized mAbs including the anti-α4 integrin mAb natalizumab, the anti-cluster of differentiation 52 (CD52) mAb alemtuzumab, and the anti-cluster of differentiation 20 (CD20) mAb ocrelizumab, were exclusively available with IV dosing regimens [ 18 ]. Ofatumumab, an anti-CD20 monoclonal antibody, has received FDA and EMA authorization for SC administration since 2020 and 2021, respectively.…”

Section: Subcutaneous (Sc) Administration Of Biotherapeutics Across S...mentioning

confidence: 99%

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: Subcutaneous (Sc) Administration Of Biotherapeutics Across S...mentioning

confidence: 99%