Biosimilars/Research
Barriers to biosimilar prescribing incentives in Spain
Incentives contribute to the proper functioning of the broader contracts that regulate the relationships between healthcare systems and professionals. Likewise, incentives are an important element of clinical governance understood as healthcare services’ management at the micro-level, aimed at achieving better health outcomes for patients.
Canada’s biosimilar substitution policy: effects on competition and patient safety
A critical review of Canada’s biosimilar substitution policy [1] finds that the scheme has focused on economic factors over other elements such as therapeutic efficacy and market competition. The authors suggest that Canada could learn from the European market, where switching policies retain choice for physicians and patients and promote competition.
Multiple successive switches between infliximab biosimilars in IBD
Recently, biosimilar tumour necrosis factor (TNF) antagonists have become available and are being increasingly used in treating inflammatory bowel diseases (IBD), Crohn’s disease (CD) and ulcerative colitis (UC). The first infliximab biosimilar to receive approval was CT-P13 (Remsima) based on data from rheumatoid arthritis and ankylosing spondylitis, followed by extrapolation to other indications of originator infliximab (Remicade). The second infliximab biosimilar, SB2 (Flixabi), received authorization based on a pharmacokinetic study in healthy volunteers and a study in rheumatoid arthritis [1].
Different approaches to the interchangeability of biosimilars
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].
Federal purchases of biological drugs for cancer in Brazil
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].
Clinical pharmacists have a critical role in increasing biosimilar uptake
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.
Clinical development of biosimilars in the oncology setting
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.
Knowledge and perceptions of naming for biosimilars in the US
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
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 in Europe: prescriber survey
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
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
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
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
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
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
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
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.
Pharmacist-driven biosimilar substitution saves money
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.
Alvotech and Celltrion proceed with adalimumab and rituximab biosimilars
Iceland-based Alvotech has reached the primary completion date in a switching study for its adalimumab biosimilar, AVT02, while Celltrion Healthcare has released real-world data on the safety and efficacy of its rituximab biosimilar, Truxima, supporting its use as a treatment for lymphoma.
Canadian study says drug formulary policies do not improve biosimilar uptake
Traditional public drug programme formulary policies alone are not effective in affecting biosimilar uptake, according to a Canadian study published in JMCP [1].
