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.
Biologicals as monoclonal antibodies (mAb) are highly complex products produced in living systems. They are included as treatment, combined with chemotherapy, for multiple common malignancies as cancer, in first- and second-line treatment regimens. However, the patient’s access to this type of treatment can be limited due to their high cost.
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 .
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 . 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 . 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.
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 . 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.
The quality of biosimilars was one of the challenges identified from the results of a survey carried out by the World Health Organization (WHO) . 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  into their regulatory practices, challenges still remain.
Researchers from Brazil investigated, from a pharmaceutical perspective, a major problem of the present time, which is the interchangeability of biosimilars .
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.
The results of a survey carried out by the World Health Organization (WHO) in 2019‒2020  revealed that, despite the efforts of the organization in helping Member States implement the evaluation principles in the WHO biosimilar guidelines  into their regulatory practices, challenges still remain. Lack of resources was one of the challenges identified from the results of the survey.
A study of pharmacist-driven substitution of brand-name biologicals with biosimilars has shown that this can lead to substantial cost savings in the setting of a community oncology practice.