Current Issue : October - December Volume : 2015 Issue Number : 4 Articles : 5 Articles
The first biosimilar monoclonal antibody (infliximab,\nCT-P13) was registered by the European Medicines\nAgency in 2013 for the treatment of several\ninflammatory conditions including rheumatoid arthritis\n(RA). Biosimilar infliximab is first being marketed in the\nCentral and Eastern European countries. This paper presents\nthe estimated budget impact of the introduction of\nbiosimilar infliximab in RA over a 3-year time period in six\nselected countries, namely Bulgaria, the Czech Republic,\nHungary, Poland, Romania and Slovakia. A prevalencebased\nmodel was constructed for budget impact analysis.\nTwo scenarios were compared to the reference scenario\n(RSc) where no biosimilar infliximab is available: biosimilar\nscenario 1 (BSc1), where interchanging the originator\ninfliximab with biosimilar infliximab is disallowed,\nand only patients who start new biological therapy are\nallowed to use biosimilar infliximab; as well as biosimilar\nscenario 2 (BSc2), where interchanging the originator\ninfliximab with biosimilar infliximab is allowed, and 80 %\nof patients treated with originator infliximab are interchanged\nto biosimilar infliximab. Compared to the RSc, the\nnet savings are estimated to be ââ??¬15.3 or ââ??¬20.8 M in BSc1\nand BSc2, respectively, over the 3 years. If budget savings\nwere spent on reimbursement of additional biosimilar infliximab\ntreatment, approximately 1,200 or 1,800 more\npatients could be treated in the six countries within 3 years\nin the two biosimilar scenarios, respectively. The actual\nsaving is most sensitive to the assumption of the acquisition\ncost of the biosimilar drug and to the initial number of\npatients treated with biological therapy. The study focused\non one indication (RA) and demonstrated that the introduction\nof biosimilar infliximab can lead to substantial\nbudget savings in health care budgets. Further savings are\nexpected for other indications where biosimilar medicines\nare implemented....
Objective The aim of this meta-analysis was to compare the\nefficacy and safety of infliximab-biosimilar and other available\nbiologicals for the treatment of rheumatoid arthritis (RA),\nnamely abatacept, adalimumab, certolizumab pegol, etanercept,\ngolimumab, infliximab, rituximab and tocilizumab.\nMethods A systematic literature review of MEDLINE\ndatabase until August 2013 was carried out to identify\nrelevant randomized controlled trials (RCTs). Bayesian\nmixed treatment comparison method was applied for the\npairwise comparison of treatments. Improvement rates by\nthe American College of Rheumatology criteria (ACR20\nand ACR50) at week 24 were used as efficacy endpoints,\nand the occurrence of serious adverse events was considered\nto assess the safety of the biologicals.\nResults Thirty-six RCTs were included in the meta-analysis.\nAll the biological agents proved to be superior to placebo. For\nACR20 response, certolizumab pegol showed the highest odds\nratio (OR) compared to placebo, OR 7.69 [95 % CI\n3.69ââ?¬â??14.26], followed by abatacept OR 3.7 [95 % CI\n2.17ââ?¬â??6.06], tocilizumab OR 3.69 [95 % CI 1.87ââ?¬â??6.62] and\ninfliximab-biosimilar OR 3.47 [95 % CI 0.85ââ?¬â??9.7]. For\nACR50 response, certolizumab pegol showed the highest OR\ncompared to placebo OR 8.46 [3.74ââ?¬â??16.82], followed by tocilizumab\nOR 5.57 [95 % CI 2.77ââ?¬â??10.09], and infliximab-biosimilar\nOR 4.06 [95 % CI 1.01ââ?¬â??11.54]. Regarding the\noccurrence of serious adverse events, the results show no statistically\nsignificant difference between infliximab-biosimilar\nand placebo, OR 1.87 [95 % CI 0.74ââ?¬â??3.84]. No significant\ndifference regarding efficacy and safety was found between\ninfliximab-biosimilar and the other biological treatments.\nConclusion This is the first indirect meta-analysis inRA that\ncompares the efficacy and safety of biosimilar-infliximab to\nthe other biologicals indicated inRA.We found no significant\ndifference between infliximab-biosimilar and other biological\nagents in terms of clinical efficacy and safety....
Deep second-degree burns are characterized by delayed formation of granulation tissue and impaired angiogenesis. Erythropoietin\n(EPO) is able to stimulate angiogenesis and mitosis, activating vascularization and cell cycle.The aim of our study was to investigate\nwhether two biosimilar recombinant human erythropoietins, EPO-? and EPO-?,may promote these processes in an experimental\nmodel of burn injury. A total of 84 mice were used and a scald burn was produced on the back after shaving, in 80?C water\nfor 10 seconds. Mice were then randomized to receive EPO-? (400 units/kg/day/sc) or EPO-? (400 units/kg/day/sc) or their\nvehicle (100 �µL/day/sc 0.9% NaCl solution). After 12 days, both EPO- and EPO-? increased VEGF protein expression. EPO-Z\ncaused an increased cyclin D1/CDK6 and cyclin E/CDK2 expression compared with vehicle and EPO-Z (P < 0.001). Our study\nshowed that EPO-? and EPO-? accelerated wound closure and angiogenesis; however EPO-? resulted more effectively in achieving\ncomplete skin regeneration. Our data suggest that EPO-Z and EPO-? are not biosimilars for the wound healing effects. The higher\nefficacy of EPO-? might be likely due to its different conformational structure leading to a more efficient cell proliferation and skin\nremodelling....
According to theWorld Health Organization, the incidence of malignant neoplasms and endocrine, blood, and immune disorders\nwill increase in the upcoming decades along with the demand of affordable treatments. In response to this need, the development of\nbiosimilar drugs is increasingworldwide.The approval of biosimilars relies on the compliance with international guidelines, starting\nwith the demonstration of similarity in their physicochemical and functional properties against the reference product. Subsequent\nclinical studies are performed to demonstrate similar pharmacological behavior and to diminish the uncertainty related to their\nsafety and efficacy.Herein we present a comparability exercise between a biosimilar trastuzumab and its reference product, by using\na hierarchical strategy with an orthogonal approach, to assess the physicochemical and biological attributes with potential impact\non its pharmacokinetics, pharmacodynamics, and immunogenicity. Our results showed that the high degree of similarity in the\nphysicochemical attributes of the biosimilar trastuzumab with respect to the reference product resulted in comparable biological\nactivity, demonstrating that a controlled process is able to provide consistently the expected product.These results also constitute\nthe basis for the design of subsequent delimited pharmacological studies, as they diminish the uncertainty of exhibiting different\nprofiles....
For small ââ?¬â?? low molecular weight ââ?¬â?? molecule medicines a robust regulatory system has evolved over the\nyears. This system guarantees high and constant quality of our (generic) medicines. Pharmaceutical\nequivalence and bioequivalence assessment are the pillars under that system. But there are complex\nmedicines where the question of equivalence is more challenging to answer. For biologicals the paradigm\nof similarity rather than equality (the emergence of ââ?¬Ë?biosimilarsââ?¬â?¢) was developed in the past decade. This\nhas been a program where an evolutionary, science based approach has been chosen by the frontrunner\nregulatory body, the EMA, with a ââ?¬Ë?learn and confirmââ?¬â?¢ character.\nIn addition, there is another group of complex drugs, the non-biological complex drugs, NBCDs, where\nthe generic paradigm can be challenged as well. The NBCDs are defined as: 1. consisting of a complex\nmultitude of closely related structures; 2. the entire multitude is the active pharmaceutical ingredient;\n3. the properties cannot be fully characterized by physicochemical analysis and 4. the consistent, tightly\ncontrolled manufacturing process is fundamental to reproduce the product. NBCDs encompass product\nfamilies such as the glatiramoids, liposomes, ironââ?¬â??carbohydrate colloids and many candidates of the\ngroup of the upcoming nanoparticulate systems. Following the main principles of regulatory pathways\nfor biologicals (with appropriate product-by-product adjustments), instead of that for small molecules,\nwould be the more logical strategy for these NBCDs.\nThe status and outstanding regulatory issues for biosimilars and NBCD-similars/follow on versions\nwere discussed at a conference in Budapest, Hungary (October 2014) and this commentary touches upon\nthe issues brought up in the presentations, deliberations and conclusions....
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