Biosimilars/Research

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.

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 QRML 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 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.

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.

Biosimilars in Spain: balance between innovation and health public expenditure

Biosimilars/Research | Posted 16/07/2021

Biosimilars have been marketed in the European Union (EU) for 13 years. Due to uncertainties about substitutability and interchangeability, their commercialization has been criticised. 

Federal purchases of biological drugs for cancer in Brazil

Biosimilars/Research | Posted 24/09/2021

Buying biosimilars is generally considered to be a way to increase access to cancer treatments in public health services. In Europe, the approval, commercialization and use of similar biotherapeutic products (SBPs) have been encouraged as a way to reduce costs and expand treatment coverage [1, 2]. In Brazil, an analysis of the profile of purchases of monoclonal antibodies (mAbs) acquired by the Unified Health System (SUS) between 2015 and 2019 showed that this premise might not be true in Brazil [2].

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].

Different approaches to the interchangeability of biosimilars

Biosimilars/Research | Posted 05/03/2021

The interchangeability of biosimilars can sometimes be an emotive subject. Despite reservations by prescribers, payers and patients, many countries have implemented policies allowing for the substitution of biologicals with biosimilars. However, there is still a lack of harmonization around the world when it comes to how different countries or regions approach the interchangeability of biosimilars [1].

Clinical pharmacists have a critical role in increasing biosimilar uptake

Biosimilars/Research | Posted 17/09/2021

The increasing global burden of chronic diseases, including cancers, diabetes, autoimmune disorders, anaemia of chronic renal failure, rheumatoid arthritis, multiple sclerosis, blood disorders and others, underscore the importance of patients’ access to safe and effective treatments. Interestingly, the introduction of biologicals in the 1980s revolutionized the treatment of these chronic diseases with better prognosis, although high costs and limited patient access remain challenges. These biologicals are known by various names, including biopharmaceutical agents, biologicals, biological therapies, biological agents and biological response modifier therapy or immunotherapy. Biologicals are derived or manufactured from a living biological system. With the majority of originator biologicals losing patent protection and the emergence of biosimilars, the landscape of biologicals is facing many changes.