Featured Publications

Featured Publications | Biosimilars Medical Academy

The list below provides links to a selection of publications addressing key topics, including biosimilars development, switching between biologics and nocebo effect.

  • Biosimilars Development and evidence
  • Nocebo Effect
  • X

Biosimilars Development and Evidence

Category: Biosimilars Development and evidence
European Commission

Biosimilars in the EU: Information Guide for Healthcare Professionals

Consensus Information Paper 2013. European Medicines Agency (EMA). Biosimilars in the EU: Information guide for healthcare professionals

Summary

Category: Biosimilars Development and evidence
Kurki P, et al.

Interchangeability of Biosimilars: A European Perspective

BioDrugs 2017;31:83-91

Summary

Category: Biosimilars Development and evidence
Vulto AG, et al.

The Process Defines the Product: What Really Matters in Biosimilar Design and Production?

Rheumatology (Oxford) 2017 1;56

Summary

Category: Biosimilars Development and evidence
Wolff-Holz E, et al.

Evolution of the EU Biosimilar Framework: Past and Future.

BioDrugs 2019

Summary

Category: Biosimilars Development and evidence
European Commission

What You Need to Know about Biosimilar Medicinal Products

Consensus Information Paper 2013. What you need to know about biosimilar Medicinal Products

Summary

Category: Biosimilars Development and evidence
Weise M, et al.

Biosimilars: The Science of Extrapolation

Blood  2014;124:3191–6

Summary

Category: Biosimilars Development and evidence
O'Callaghan J.

Regulation of Biosimilar Medicines and Current Perspectives on Interchangeability and Policy.

Eur J Clin Pharmacol  2018. doi: 10.1007/s00228-018-2542-1 [Epub ahead of print]

Summary

Category: Biosimilars Development and evidence
Schiestl M, et al.

Acceptable Changes in Quality Attributes of Glycosylated Biopharmaceuticals

Nat Biotechnol 2011;29:310–2

Summary

Category: Biosimilars Development and evidence
Vezér B, et al.

Authorized Manufacturing Changes of Therapeutic Monoclonal Antibodies (mAbs) in European Public Assessment Report (EPAR) Documents

Curr Med Res Opin 2016;32:829–34

Summary

Nocebo Effect

Category: Nocebo Effect
Sharma A, et al.

Need of Education on Biosimilars Amongst Ophthalmologists: Combating the Nocebo Effect.

Eye (Lond). 2019 Nov 29.

Summary

Category: Nocebo Effect
Benedetti F, et al.

The Neurobiological Underpinnings of Placebo and Nocebo Effects.

Semin Arthritis Rheum. 2019 Dec;49(3S):S18-S21

Summary

Category: Nocebo Effect
Spanou I, et al.

Nocebo in Biosimilars and Generics in Neurology: A Systematic Review.

Front Pharmacol. 2019 Jul 24;10:809.

Summary

Category: Nocebo Effect
Pouillon L, et al.

Consensus Report: Clinical Recommendations for the Prevention and Management of the Nocebo Effect in Biosimilar-treated IBD Patients

Aliment Pharmacol Ther 2019;49:1181-1187

Summary

Category: Nocebo Effect
Rezk MF and Pieper B.

To See or NOsee: The Debate on the Nocebo Effect and Optimizing the Use of Biosimilars.

Adv Ther 2018;35:749–753

Summary

Category: Nocebo Effect
Rezk MF and Pieper B.

Treatment Outcomes with Biosimilars: Be Aware of the Nocebo Effect.

Rheumatol Ther 2017;4:209–218

Summary

Category: Nocebo Effect
Kristensen KE, et al.

Non-pharmacological Effects in Switching Medication: The Nocebo Effect in Switching from Originator to Biosimilar Agent.

BioDrugs 2018;32:397–404

Summary

Category: Nocebo Effect
Odinet JS, et al.

The Biosimilar Nocebo Effect: A Systemic Review of Double-blinded vs Open-label Studies.

J Manag Care Spec Pharm 2018;24:952–9

Summary

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