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.

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.

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.

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.

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.

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

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.

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.

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.

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.

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.

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.