Featured Publications | Biosimilars Medical Academy

The list below provides links to a selection of publicly available abstracts for 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
Vulto AG, et al.

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

Rheumatology (Oxford) 2017 1;56

Summary

Critical quality attributes (CQA) of a biologic are subject to post-translational variations at the cellular and/or manufacturing level. One of the founding principles of the biosimilarity exercise is to closely match the biosimilar’s fingerprint with that of its reference product. Therefore, and in contrast to original biological agents, the emphasis in biosimilar development is on analytical and nonclinical attributes. The manufacturer's ability to provide consistent production and quality control will greatly influence the acceptance of its biosimilar products.

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

Biosimilars: The Science of Extrapolation

Blood  2014;124:3191–6

Summary

This article addresses the concerns frequently raised in the medical community regarding the use of biosimilars in extrapolated indications and explains the underlying scientific and regulatory decision making, including some real-life examples from recently licensed biosimilars. This article is an extension to a paper published previously by Weise et al. (Blood 2012;120:5111–5117) which explained the principles of biosimilar development in general.

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

The differences between FDA and EMA interchangeability recommendations for biosimilar therapeutics are discussed in this review. USA federal policy is contrasted with that of the EMA – ‘interchangeable products’ are evaluated in the former, whereas the EMA does not assess interchangeability. Policies promoting the use of biosimilar medicines in a number of European countries, the USA and Australia are discussed.

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

Acceptable Changes in Quality Attributes of Glycosylated Biopharmaceuticals

Nat Biotechnol 2011;29:310–2

Summary

This study analyses the quality profiles of the glycosylated biologics darbepoetin alfa, rituximab and etanercept and debates acceptable variations in quality attributes. This data, sourced from the market between 2007 and 2010, provides examples of acceptable variations for products that have remained on the market with unchanged product labels.

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

In this comment, authors describe the transformative effect of biologics in the treatment of diseases of the retina and the efforts to address patients’ non-compliance, driven by high-cost of biologics, through developing new biologics as well as biosimilars of already existing originators. Education around biosimilars among ophthalmologists need to be revisited and topics such as nocebo addressed.

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

In this study, authors discuss the effects of language and psychosocial context on patients’ response to their treatment and course of disease.

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

A systematic review where the aim was to estimate the magnitude of nocebo in generics and biosimilars available to treat different neurological diseases and propose strategies to minimize its prevalence both in clinical practice and clinical trials.

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

The nocebo effect is under-recognised in the era of biosimilars, although it may negatively impact on the cost-savings of biosimilars. Future research should focus on the magnitude, the risk factors, the impact, and the management of the nocebo effect in biosimilars-treated IBD patients.

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

The authors take a closer look at the negative impact of the nocebo effect, as reported in a number of clinical trials, and its implications on patients’ perception when switching from an originator biologic to a biosimilar.

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

The authors focus on the wide adoption of biosimilars, the re-emergence of the nocebo effect and the implications it may have on both patients and physicians’ perceptions as well as on treatment success. The authors also provide practical strategies and recommendations to raise awareness and to limit the nocebo effect.

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

This review investigates the nocebo effect, defining the term and considering it in the process of switching from originator products to biosimilars. Three strategies aimed at mitigating the nocebo effect are discussed: positive framing, increasing patients and HCPs understanding of biosimilars and managed switching programs.

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

This publication reviews 31 trials, involving a total of 3,271 patients, to analyse the potential role of a nocebo effect in the arising of treatment-emergent adverse events in switching studies.

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