A review of bridging clinical studies between different presentations of biological products approved by the United States Food and Drug Administration (US FDA)

Patel, Ronak; Ghadge, Pravin; Nair, Pravin; Kumar, Manish; Adhikary, Laxmi

doi:10.1080/14712598.2022.2113053

Cited by 1 publication

(3 citation statements)

References 29 publications

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“…Sihem Ait-Oudhia 1 , Yow-Ming Wang 2 , Anne-Gaelle Dosne 3 , Amit Roy 4 , Jin Y. Jin 5 , Jun Shen 4 , Leonid Kagan 6 , Flora T. Musuamba 7,8 , Lucia Zhang 9 , Shinichi Kijima 10 , Marc R. Gastonguay 11 and Daniele Ouellet 12, * The transition from intravenous (i.v.) to subcutaneous (s.c.) administration of biologics is a critical strategy in drug development aimed at improving patient convenience, compliance, and therapeutic outcomes.…”

Section: Challenging the Norm: A Multidisciplinary Perspective On Int...mentioning

confidence: 99%

“…However, a change in the route of administration presents additional challenges for both drug developers and regulators (Figure 1). [2][3][4] Transitioning from i.v. to s.c. dosing can dramatically improve a patient's acceptability of treatment and quality of life.…”

Section: Challenging the Norm: A Multidisciplinary Perspective On Int...mentioning

confidence: 99%

“…Modeling approaches have been used to optimize bridging strategies across dosing regimens to gain regulatory approval. However, a change in the route of administration presents additional challenges for both drug developers and regulators ( Figure ) 2–4 …”

Section: Figurementioning

confidence: 99%

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Challenging the Norm: A Multidisciplinary Perspective on Intravenous to Subcutaneous Bridging Strategies for Biologics

Ait‐Oudhia,

Wang,

Dosne

et al. 2023

Clin Pharma and Therapeutics

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The transition from intravenous (i.v.) to subcutaneous (s.c.) administration of biologics is a critical strategy in drug development aimed at improving patient convenience, compliance, and therapeutic outcomes. Focusing on the increasing role of model‐informed drug development (MIDD) in the acceleration of this transition, an in‐depth overview of the essential clinical pharmacology, and regulatory considerations for successful i.v. to s.c. bridging for biologics after the i.v. formulation has been approved are presented. Considerations encompass multiple aspects beginning with adequate pharmacokinetic (PK) and pharmacodynamic (i.e., exposure‐response) evaluations which play a vital role in establishing comparability between the i.v. and s.c. routes of administrations. Selected key recommendations and points to consider include: (i) PK characterization of the s.c. formulation, supported by the increasing preclinical understanding of the s.c. absorption, and robust PK study design and analyses in humans; (ii) a thorough characterization of the exposure‐response profiles including important metrics of exposure for both efficacy and safety; (iii) comparability studies designed to meet regulatory considerations and support approval of the s.c. formulation, including noninferiority studies with PK and/or efficacy and safety as primary end points; and (iv) comprehensive safety package addressing assessments of immunogenicity and patients' safety profile with the new route of administration. Recommendations for successful bridging strategies are evolving and MIDD approaches have been used successfully to accelerate the transition to s.c. dosing, ultimately leading to improved patient experiences, adherence, and clinical outcomes.

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Section: Challenging the Norm: A Multidisciplinary Perspective On Int...mentioning

confidence: 99%

Section: Challenging the Norm: A Multidisciplinary Perspective On Int...mentioning

confidence: 99%

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Challenging the Norm: A Multidisciplinary Perspective on Intravenous to Subcutaneous Bridging Strategies for Biologics

Ait‐Oudhia,

Wang,

Dosne

et al. 2023

Clin Pharma and Therapeutics

View full text Add to dashboard Cite

show abstract

A review of bridging clinical studies between different presentations of biological products approved by the United States Food and Drug Administration (US FDA)

Cited by 1 publication

References 29 publications

Challenging the Norm: A Multidisciplinary Perspective on Intravenous to Subcutaneous Bridging Strategies for Biologics

Challenging the Norm: A Multidisciplinary Perspective on Intravenous to Subcutaneous Bridging Strategies for Biologics

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