Current Issue : October-December Volume : 2021 Issue Number : 4 Articles : 6 Articles
Reports of the prevalence of antibodies to infliximab (anti-drug antibodies, ADA) are inconsistent due in part to the various assay formats used to monitor immunogenicity in the clinic and under clinical trial settings. This study aimed to determine the frequency of ADA in patients with inflammatory bowel disease (IBD) during induction and maintenance therapy with biosimilar infliximab (CT-P13) using the ELISA (enzyme-linked immunosorbent assay) method. In this prospective single-center study, we analyzed the incidence of ADA and the relationship between the presence of ADA and the following variables: gender, type of disease, immunosuppressive therapy used, and duration of treatment. A total of 84 patients with IBD received CT-P13 and were followed up for an average of 7 months. We found ADA in 50% of the patients with undetectable levels of the drug. The percentage of persons with antibodies detected during induction treatment was 11.3% compared to 9.6% during maintenance therapy. The analysis showed no relationship between response to treatment and antibody titers (p = 0.381). The study showed a statistically significant relationship between undetectable levels of CT-P13 and the presence of ADA at week 6 of therapy (i.e., ADA were detected in all the patients with undetectable levels of CT-P13). Patients with IBD and undetectable levels of CT-P13 before administration of the third induction dose were at high risk of the presence of anti-drug antibodies as well as primary non-response....
The aim was to explore the availability of biosimilar insulins on the national market in Bulgaria and their impact on prices and utilization. This was a retrospective, quantitative, longitudinal study during the period 2014–2020. Authorized-for-sale, biosimilar insulins at the European level were compared with those on the national market. Prices and utilization were compared in value, number of defined daily dose (DDD), and DDD/1000 inh/day. Almost all types of insulins possessed biosimilars, and even more than one on the European market, but only two were found to be available and reimbursed on the national market. The total number of reimbursed INNs was 11, and for seven of them, changes in reference price per DDD were found. The highest price decrease was observed for insulin (price per DDD decline from 2.77 to 2.22 Bulgarian Leva (BGN)). The total expenditure for insulin increased from 68 to approximately 72.8 mil BGN (34 to approximately 37 mil Euro). The utilization in DDD/1000/inh/day decreased from 16.12 to 15.31. Only two biosimilar insulins were found to be available on the national market, with a slow decrease in prices and stable utilization. Other regulatory and financial measures are probably necessary to foster the insulins’ competition at the biosimilar level....
This commentary summarizes a collection of key references published within the last ten years, and identifies pharmacologic research directions to improve treatment access and success through greater biosimilar or “follow-on” biologic utilization combined with other targeted small molecule agents that possess unique pathophysiologic mechanisms for inflammatory bowel diseases (IBD) in adult and pediatric patients. Since they are not identical to the originator or reference biologic agent, all biosimilars are not generically equivalent. However, in the US and other countries, they are considered therapeutically interchangeable if the manufacturer has demonstrated no clinically meaningful differences from the reference product. Comparisons of different clinical initiation and switching scenarios are discussed with reference to interchangeability, immunogenicity, nocebo effect, cost effectiveness, and time courses for discontinuation rates....
Analytical biosimilarity assessment relies on two implicit conditions. First, the analytical method must meet a set of requirements known as fit for intended use related to trueness and precision. Second, the manufacture of the reference drug product must be under statistical quality control; i.e., the between-batch variability is not larger than the expected within-batch variability. In addition, the quality range (QR) method is based on one sample per batch to avoid biased standard deviations in unbalanced studies. This, together with the small number of reference drug product batches, leads to highly variable QR bounds. In this paper, we propose to set the QR bounds from variance components estimated using a two-level nested linear model, accounting for between- and within-batch variances of the reference drug product. In this way, the standard deviation used to set QR is equal to the square root of the sum of between-batch variance plus the within-batch variance estimated by the maximum likelihood method. The process of this method, which we call QRML, is as follows. First, the condition of statistical quality control of the manufacture process is tested. Second, confidence intervals for QR bounds lead to an analysis of the reliability of the biosimilarity assessment. Third, after analyzing the molecular weight and dimer content of seven batches of a commercial bevacizumab drug product, we concluded that the QRML method was more reliable than QR....
This study aimed to compare drug costs and healthcare costs of a 1 year adjuvant course with intravenous biosimilar trastuzumab vs. subcutaneous reference trastuzumab in HER2-positive breast cancer from the Belgian hospital perspective. Our simulation is based on the methodology used by Tjalma and colleagues, and considered costs of drugs, healthcare professional time and consumables. We calculated intravenous drug costs for different body weights, and computed drug costs and healthcare costs to treat 100 patients with either trastuzumab formulation, assuming a binomial body weight distribution in this sample. Scenarios were run to account for drug discounts and intravenous vial sharing. Drug costs amounted to 1,431,282 with intravenous biosimilar trastuzumab and 1,522,809 with subcutaneous reference trastuzumab for a sample of 100 patients in the base case analysis. When healthcare professional time and consumables were also considered, healthcare costs with intravenous biosimilar trastuzumab were similar to those with subcutaneous reference trastuzumab. Differences in healthcare costs between intravenous biosimilar trastuzumab and subcutaneous reference trastuzumab depended on the level of discounts on these formulations and on intravenous vial sharing. Our case study demonstrates that comparing costs of intravenous vs. subcutaneous formulations is complex and multifactorial, and entails more than a simple cost comparison of products....
Biosimilars are cheaper than original drugs and are thus of interest to the public. The aim of this article is to assess the benefits of introducing more than one biosimilar for the same substance (active pharmaceutical ingredient, API). The hypothesis is that the introduction of successive biosimilars of a specific original drug reduces the price of the selected API. The study focuses on drug prices varying with the successive arrival of new biosimilars. Three drugs that have at least three reimbursed biosimilars on the market were selected, two from the same therapeutic group (adalimumab and infliximab) and one (trastuzumab) representing another class of drugs. The following data were analyzed: price variation after the introduction of the first, second, and third biosimilar, and the average price reduction for all three biosimilars. Additionally, a literature review was conducted. The reimbursement of each new biosimilar is beneficial since it is associated with a price reduction in percentage terms. However, the first biosimilar brought about the greatest savings due to the higher initial prices of the original drugs and to Polish reimbursement rules. This article is helpful for when taking healthcare decisions regarding the pricing of and reimbursement for new biosimilars....
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