Biosimilars/Research

Knowledge and perceptions of naming for biosimilars in the US

Biosimilars/Research | Posted 10/09/2021

The relatively recent introduction of biosimilars to the US market and the new naming convention for biopharmaceuticals prompted exploration of their impact in clinical practice. Naming guidance for new biological products and biosimilars was published by the US Food and Drug Administration (FDA) in 2017, which proposed the use of a core name followed by a 4-letter suffix devoid of meaning to facilitate pharmacovigilance [1]. In order to find out how this system was viewed by healthcare providers, researchers evaluated use of, knowledge about, perceptions of, and preferences for this naming convention in clinical practice [2]. Previous studies informed the hypothesis that healthcare providers would demonstrate knowledge gaps surrounding biosimilars and opinions regarding 4-letter suffix use would be inconsistent. This study aimed to understand the impact of the recent naming guidance in clinical practice.

New quality-range-setting method for biosimilarity assessment

Biosimilars/Research | Posted 10/09/2021

Spanish researchers present a new method for the estimation of quality range (QR) bounds based on the variance components to account for both between-lots and within-lots variability; variance components are computed by the maximum likelihood method using a linear random model [1]. The authors have called this method QR_ML to differentiate it from the currently used procedure based on one sample per batch. For this, the molecular weight (Mw) and dimer content (expressed as percentage) were used as critical quality attributes (CQAs). Real data from seven batches of a commercial bevacizumab drug product were used.

Biosimilars in Europe: prescriber survey

Biosimilars/Research | Posted 26/03/2021

A survey of European prescribers reveals a significant increase in familiarity with biosimilars since 2013 [1]. In addition, prescribers increasingly believe they should always have control of treatment decisions, including those to switch to a biosimilar.

Long-term safety and efficacy of anti-TNF-α biosimilars in psoriasis

Biosimilars/Research | Posted 24/09/2021

Biologicals have greatly improved treatment options and outcomes for patients with moderate-to severe psoriasis. Despite being significantly more effective than conventional systemic agents for psoriasis, the high cost of biologicals may limit their use [1].

Biosimilars and interchangeability in oncology

Biosimilars/Research | Posted 03/09/2021

Researchers from Brazil investigated, from a pharmaceutical perspective, a major problem of the present time, which is the interchangeability of biosimilars [1].

Biosimilar interchangeability and emerging treatment strategies for IBD

Biosimilars/Research | Posted 03/09/2021

Biosimilar development and utilization, as well as non-biological oral agents with unique pathological targets, will continue to dominate efforts to improve patient access and reduce the overall cost of care as non-surgical treatments for Crohn’s disease and ulcerative colitis in adults and children. Therapeutic drug monitoring, combined with inflammatory biomarkers, have become the standard of care to assess effectiveness.

Collaboration between regulatory authorities for biosimilars

Biosimilars/Research | Posted 26/02/2021

A survey carried out by the World Health Organization (WHO) in 2019‒2020 highlighted the need for collaboration between regulatory authorities in order to expediate the approval of biosimilars [1].

Approaches to naming and labelling of biosimilars

Biosimilars/Research | Posted 12/03/2021

Naming and labelling of biosimilars has been a controversial issue and there is a long-standing debate regarding the naming of biologicals.

Regulatory issues related to quality of biosimilars

Biosimilars/Research | Posted 05/02/2021

The quality of biosimilars was one of the challenges identified from the results of a survey carried out by the World Health Organization (WHO) [1]. The survey, which was carried out in 2019‒2020, revealed that despite the efforts of WHO in helping Member States implement the evaluation principles in the WHO biosimilar guidelines [2] into their regulatory practices, challenges still remain.

Biosimilars and lack of resources

Biosimilars/Research | Posted 22/01/2021

The results of a survey carried out by the World Health Organization (WHO) in 2019‒2020 [1] revealed that, despite the efforts of the organization in helping Member States implement the evaluation principles in the WHO biosimilar guidelines [2] into their regulatory practices, challenges still remain. Lack of resources was one of the challenges identified from the results of the survey.