Biosimilars: Current regulatory perspective and challenges

Jha, Diwakar; Mishra, Ram Kumar; Pandey, Rishabh Deo

doi:10.4103/0975-7406.106569

Cited by 3 publications

(2 citation statements)

References 1 publication

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“…The questionnaire comprised 46 questions classified into 5 sections (Table 1): the first section recorded participant demographics, specialty, and level of experience (6 questions); the second section focused on practices and attitudes toward biosimilar use in clinical practice (22 questions); the third section dealt with interchangeability, including reverse and multiple switches (9 questions); the fourth section addressed the nocebo effect and nonmedical switch (5); and the last section covered current and future perspectives (4 questions). Only the demographic questions were mandatory, and the number of respondents was reported for each question to account for missing data.…”

Section: Surveymentioning

confidence: 99%

“…From a regulatory standpoint, a robust legal framework has been put in place, and ever since the first biosimilar received approval, the European Medicines Agency (EMA) has implemented a specific pathway for biosimilar approval. This pathway relies on a thorough comparability exercise to ascertain biosimilarity [5,6]. Biosimilars undergo testing for at least one indication of the originator in phase I and III clinical trials, and the results may be extrapolated to other indications [7,8].…”

Section: Introductionmentioning

confidence: 99%

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Practical Management of Biosimilar Use in Inflammatory Bowel Disease (IBD): A Global Survey and an International Delphi Consensus

D’Amico,

Solitano,

Magro

et al. 2023

JCM

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As the patents for biologic originator drugs expire, biosimilars are emerging as cost-effective alternatives within healthcare systems. Addressing various challenges in the clinical management of inflammatory bowel disease (IBD) remains crucial. To shed light on physicians’ current knowledge, beliefs, practical approaches, and concerns related to biosimilar adoption—whether initiating a biosimilar, transitioning from an originator to a biosimilar, or switching between biosimilars (including multiple switches and reverse switching)—a global survey was conducted. Fifteen physicians with expertise in the field of IBD from 13 countries attended a virtual international consensus meeting to develop practical guidance regarding biosimilar adoption worldwide, considering the survey results. This consensus centered on 10 key statements covering biosimilar effectiveness, safety, indications, rationale, multiple switches, therapeutic drug monitoring of biosimilars, non-medical switching, and future perspectives. Ultimately, the consensus affirmed that biosimilars are equally effective and safe when compared to originator drugs. They are considered suitable for both biologic-naïve patients and those who have previously been treated with originator drugs, with cost reduction being the primary motivation for transitioning from an originator drug to a biosimilar.

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Section: Surveymentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Practical Management of Biosimilar Use in Inflammatory Bowel Disease (IBD): A Global Survey and an International Delphi Consensus

D’Amico,

Solitano,

Magro

et al. 2023

JCM

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Perception of Originator Biologics and Biosimilars: A Survey Among Belgian Rheumatoid Arthritis Patients and Rheumatologists

et al. 2017

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Practical Management of Biosimilar Use in Inflammatory Bowel Disease (IBD): A Global Survey and an International Delphi Consensus

D’Amico,

Solitano,

Magro

et al. 2023

Preprint

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While biologic originators’ patents are expiring, biosimilars are emerging to take their place, offering significant cost savings to healthcare systems. Many challenges still need to be addressed in the clinical practice of inflammatory bowel disease (IBD). A global survey was organized to highlight physicians’ current knowledge and beliefs and to gain insight about their practical management and remaining concerns and obstacles associated with starting a biosimilar, switching from an originator to a biosimilar, or switching from one biosimilar to another (multiple switches and reverse switching). Fifteen physicians with expertise in the field of IBD from 13 countries attended a virtual international consensus meeting to develop practical guidance regarding biosimilar adoption worldwide, considering the survey results. Consensus was reached on 10 statements regarding biosimilar effectiveness, safety, indications and rationale, multiple switches, therapeutic drug monitoring of biosimilars, non-medical switching and future perspectives.

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Biosimilars: Current regulatory perspective and challenges

Cited by 3 publications

References 1 publication

Practical Management of Biosimilar Use in Inflammatory Bowel Disease (IBD): A Global Survey and an International Delphi Consensus

Practical Management of Biosimilar Use in Inflammatory Bowel Disease (IBD): A Global Survey and an International Delphi Consensus

Perception of Originator Biologics and Biosimilars: A Survey Among Belgian Rheumatoid Arthritis Patients and Rheumatologists

Practical Management of Biosimilar Use in Inflammatory Bowel Disease (IBD): A Global Survey and an International Delphi Consensus

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