Current Issue : October - December Volume : 2014 Issue Number : 4 Articles : 4 Articles
Z 8 % \nindustry over the next decade, mainly because of the current market penetration of\nbiologics and the need to provide payers cost savings over the originator therapeutics.\nLegislative support and regulatory guidance have facilitated their entry into pharmacy\nformularies of the future. Unlike small molecule generic drugs, biosimilars are\nheterogeneous proteins manufactured using cell-based systems of either microbial or\nmammalian origin. The use of living systems to manufacture drugs raises challenges\nin terms of product characterization and therapeutic equivalence to the innovator\nprotein therapeutic. In this article, we share some lessons learned from developing\nand validating pharmacokinetic and immunogenicity assays that support preclinical\nand clinical comparative studies for the development of biosimilars....
Aim: This observational clinical study tested the effect of injection frequency of the biosimilar epoetin zeta on the\nweekly dose needed to maintain stable hemoglobin levels in chronic kidney diseases (CKD) patients on intermittent\nhigh-flux hemodialysis (HD). Patients and Methods: CKD patients (n = 33) on regular HD therapy 3 times a week\nwere treated for 18 months with epoetin zeta i.v. The hemoglobin levels, the weekly dose as well as the injection frequency\nof epoetin zeta were monitored at least every two weeks. Patients were followed in three time periods: 1) extended\nfollow-up (months 1 - 18); 2) intervention phase (months 19 - 21); and 3) post intervention observation phase\n(months 28 - 30). During extended follow-up the majority of patients (n = 21) received only one injection of epoetin\nzeta per week. During the intervention phase, injection frequency was increased to 3 injections per week in all patients\naccompanied by a reduction in weekly doses of approximately 20% - 30%. Following a 9-month period of dose adjustment\nall parameters were monitored again in the post-intervention phase. Results: During the first 18 months of epoetin\nzeta therapy the mean hemoglobin level was stable between 11 and 12 g/dl. The mean weekly dose of epoetin zeta was\n7939 IU/week in month 6 and 7909 IU/week in month 18 (p = not significant). The mean frequency (injections/week)\nwas 1.27 in month 6 and 1.29 in month 18 (not significant). Compared to month 18, at the end of the observation at\nmonth 30, hemoglobin levels were stable, mean injection frequency increased to 2.25 (p < 0.001) and the mean weekly\ndose decreased to 5469 IU/week (31.7%, p < 0.001). Conclusions: Increasing the injection frequency of the short acting\nbiosimilar epoetin zeta to two to three injections per week reduces the weekly dose and thereby the costs of ESA\ntherapy of renal anemia significantly....
Biosimilars are defined as the biotechnological products having patent expired and are found to possess almost similar properties as that of innovator products. In the next coming years there is great line up standing for patent expiry means there would be great blockbuster coming now. India is a hub of generic medicines means similar trend will be followed for the production of biosimilar products. So there is great need for the development of some strict guidelines as the principles followed in case of pharmaceutical drugs could not be applied over it. In this review the present scenario regarding the biosimilar is provided and also describes the drawbacks of the present system....
For decades, policies regarding generic medicines have sought to provide patients with economical access to safe and\neffective drugs, while encouraging the development of new therapies. This balance is becoming more challenging for\nphysicians and regulators as biologics and non-biological complex drugs (NBCDs) such as glatiramer acetate demonstrate\nremarkable efficacy, because generics for these medicines are more difficult to assess. We sought to develop computational\nmethods that use transcriptional profiles to compare branded medicines to generics, robustly characterizing differences in\nbiological impact. We combined multiple computational methods to determine whether differentially expressed genes\nresult from random variation, or point to consistent differences in biological impact of the generic compared to the branded\nmedicine. We applied these methods to analyze gene expression data from mouse splenocytes exposed to either branded\nglatiramer acetate or a generic. The computational methods identified extensive evidence that branded glatiramer acetate\nhas a more consistent biological impact across batches than the generic, and has a distinct impact on regulatory T cells and\nmyeloid lineage cells. In summary, we developed a computational pipeline that integrates multiple methods to compare\ntwo medicines in an innovative way. This pipeline, and the specific findings distinguishing branded glatiramer acetate from\na generic, can help physicians and regulators take appropriate steps to ensure safety and efficacy....
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