Current Issue : July - September Volume : 2015 Issue Number : 3 Articles : 5 Articles
Objectives To compare the efficacy and safety of infliximab-\nbiosimilar with other biological drugs for the treatment\nof active ankylosing spondylitis (AS).\nMethods Systematic literature review for randomized\ncontrolled trials (RCTs) with adalimumab, etanercept, golimumab,\ninfliximab and infliximab-biosimilar in AS was\nperformed and indirect meta-analysis (Bayesian mixed\ntreatment comparison) was carried out. The proportion of\npatients reaching 20 % improvement by the assessment of\nSpondyloarthritis International Society response criteria\n(ASAS20) at weeks 12 and 24 was used as efficacy endpoints,\nand the occurrence of serious adverse events at week\n24 was applied to compare the safety of the biologicals.\nResults Altogether, 13 RCTs, identified by the systematic\nliterature search, were included in the analysis. Results on\nthe ASAS20 efficacy endpoint were reported for week 12\nin 12 RCTs involving 2,395 patients, and for week 24 in 5\nRCTs comprising 1,337 patients. All the five biological\nagents proved to be significantly superior to placebo. Infliximab\nshowed the highest odds ratio (OR) of 7.2 (95 %\nCI 3.68ââ?¬â??13.19) compared to placebo, followed by infliximab-\nbiosimilar with OR 6.25 (95 % CI 2.55ââ?¬â??13.14), both\nassessed at week 24. No significant difference was found\nbetween infliximab-biosimilar and other biological treatments\nregarding their efficacy and safety.\nConclusions This is the first study which includes a\nbiosimilar drug in the meta-analysis of biological treatments\nin AS. The results have proven the similar efficacy\nand safety profile of infliximab-biosimilar treatment compared\nto other biologicals....
Etanercept was the first tumour necrosis factor\nalpha antagonist approved in the USA for the treatment of\nrheumatoid arthritis, in 1998, and then for other diseases.\nWith the etanercept patent set to expire in the EU in 2015,\na number of etanercept copies have reached the production\nphase and are undergoing clinical trials, with the promise\nof being cheaper alternatives to the reference product. In a\nglobal scenario that is favourable to the entry of biosimilars,\nthis article discusses the stage of development, manufacture,\nclinical trials and the regulatory process involved\nin the approval of etanercept biosimilars, compiling the\nliterature data. Reducing treatment cost is the principal\nattraction for biosimilars to emerge in the global market.\nIt is essential for the doctors� decision on the prescription\nof these medications, as well as for payers, to have clearly\ndefined studies of clinical equivalence, quality, and safety\nin order to better evaluate the various copies of etanercept.\nThe authors discuss the need to harmonize different\nnational regulations and the introduction of effective\npharmacosurveillance systems for prompt recognition of\nadverse effects in copies of biopharmaceuticals that differ\nfrom those found in the reference products....
The use of biotechnology-derived medicines has\nsignificantly increased in recent decades. Although\nbiosimilars undergo rigorous characterization as well as clinical\nstudies to document their safety and effectiveness, they\nare highly complex molecules and small changes in the purification\nand production process of a biosimilar can have major\nimplications in its safety and effectiveness profile. In Latin\nAmerica, regulatory authorities have begun to establish welldescribed\nand standardized pathways that permit a biosimilar\nto gain commercial licensure. In order to be certain that a\nbiosimilar reaches its potential in ordinary clinical use, an intensive\npost-licensing monitoring system must be established\nsince it is the only means to ascertain the true similarity between\nthe original biologic and its biosimilar. Pharmacovigilance allows\nnational authorities to determine a drug�s performance in\nthe marketplace. An effective tracking and pharmacovigilance\nsystem for biological medicines has many steps and processes.\nTo aid policy makers in Latin American in addressing the many\nissues surrounding the establishment of an effective\npharmacovigilance system, the Americas Health Foundation\nconvened a group of experts to discuss the topic and develop\nrecommendations for implementation. The group discussed\ncurrent challenges and gaps in pharmacovigilance in Latin\nAmerica, paying close attention to the major issues associated\nwith traceability and pharmacovigilance of biosimilars following\ntheir approval. The recommendations developed should\nenable countries to accurately document the safety and performance\nof a biosimilar as experienced by patients under real-life\nconditions and have a significant impact on the successful implementation\nof pharmacovigilance of biosimilars throughout\nthe region....
When the patent of a brand-name, marketed drug\nexpires, new, generic products are usually offered. Smallmolecule\ngeneric and originator drug products are expected\nto be chemically identical. Their pharmaceutical similarity\ncan be typically assessed by simple regulatory criteria such\nas the expectation that the 90 % confidence interval for the\nratio of geometric means of some pharmacokinetic parameters\nbe between 0.80 and 1.25. When such criteria are satisfied,\nthe drug products are generally considered to exhibit\ntherapeutic equivalence. They are then usually interchanged\nfreely within individual patients. Biological drugs are complex\nproteins, for instance, because of their large size, intricate\nstructure, sensitivity to environmental conditions,\ndifficult manufacturing procedures, and the possibility of\nimmunogenicity. Generic and brand-name biologic products\ncan be expected to show only similarity but not identity in\ntheir various features and clinical effects. Consequently, the\ndetermination of biosimilarity is also a complicated process\nwhich involves assessment of the totality of the evidence for\nthe close similarity of the two products. Moreover, even\nwhen biosimilarity has been established, it may not be\nassumed that the two biosimilar products can be automatically\nsubstituted by pharmacists. This generally requires\nadditional, careful considerations. Without declaring interchangeability,\na new product could be prescribed, i.e. it is\nprescribable. However, two products can be automatically\nsubstituted only if they are interchangeable. Interchangeability\nis a statistical term and it means that products can be\nused in any order in the same patient without considering the\ntreatment history. The concepts of interchangeability and\nprescribability have been widely discussed in the past but\nonly in relation to small molecule generics. In this paper we\napply these concepts to biosimilars and we discuss: definitions\nof prescribability and interchangeability and their statistical\nimplementation; the relation between bioequivalence\nand interchangeability for small-molecule drug products;\nregulatory requirements and expectations of biosimilar\nproducts in various jurisdictions; possible statistical\napproaches to establish the similarity and interchangeability\nof biologic drug products; definition of other technical terms\nsuch as switchability and automatic substitution. The paper\nwill be concluded with a discussion of the anticipated future\nuse of interchangeability of biological drug products...
Rheumatic and musculoskeletal diseases (RMDs)\nrepresent a multitude of degenerative, inflammatory and autoimmune\nconditions affecting millions of people worldwide.\nPersons with these diseases may potentially experience severe\nchronic pain, joint damage, increasing disability and even\ndeath.With an increasingly ageing population, the prevalence\nand burden of RMDs are predicted to increase, placing greater\ndemands on the global practice of rheumatology and related\nhealthcare budgets. Effective treatment of RMDs currently\nfaces a number of challenges in both the developed and\ndeveloping world, and individual countries may face more\nspecific local challenges. However, limited understanding of\nthe burden of RMDs amongst public health professionals and\npolicy-makers means that these diseases are often not considered\na public health priority. The objective of this review is to\nincrease awareness of the RMDs and to identify opportunities\nto address RMD challenges on both a local and global scale.\nOn 26 September 2014, rheumatology experts from five different\ncontinents met at the World Forum on Rheumatic and\nMusculoskeletal Diseases (WFRMD) to discuss and identify...
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