Most commonly used precursor ion intensity based quantification method is less accurate and other labeled methods are expensive and require enrichment of glycopeptides. The site-specific quantitation of N- and O-glycosylation is vital to understanding the function(s) of different glycans expressed at a given site of a protein under physiological and disease conditions. Pharmacosurveillance systems for prompt recognition ofĪdverse effects in copies of biopharmaceuticals that differįrom those found in the reference products. National regulations and the introduction of effective The authors discuss the need to harmonize different In order to better evaluate the various copies of etanercept. Of these medications, as well as for payers, to have clearlyĭefined studies of clinical equivalence, quality, and safety It is essential for the doctors’ decision on the prescription Reducing treatment cost is the principalĪttraction for biosimilars to emerge in the global market. In the approval of etanercept biosimilars, compiling the This article discusses the stage of development, manufacture,Ĭlinical trials and the regulatory process involved Global scenario that is favourable to the entry of biosimilars, Of being cheaper alternatives to the reference product. Phase and are undergoing clinical trials, with the promise With the etanercept patent set to expire in the EU in 2015,Ī number of etanercept copies have reached the production Rheumatoid arthritis, in 1998, and then for other diseases. Significant gaps exist particularly for intended copies, reinforcing the need to maintain a clear differentiation between these molecules and true biosimilars.Įtanercept was the first tumour necrosis factorĪlpha antagonist approved in the USA for the treatment of While most agents display a moderate to high degree of similarity to their originator in the published studies identified, large discrepancies persist in the overall amount and type of data available in the public domain. Thematic analysis of non-empirical publications showed that indication extrapolation remains an issue, particularly for gastroenterologists. Four intended copies were identified in published studies (total: n = 1430 n = 1372 in observational studies). Published data were not available for ongoing studies in psoriasis patients. At data cut-off, only CT-P13 had published data in ankylosing spondylitis (n = 250 randomized control trial) and ulcerative colitis/Crohn's disease (n = 336 observational studies). Across indications, approved biosimilars infliximab CT-P13, SB2, and etanercept SB4 have published studies involving the largest number of patients or healthy subjects (n = 1405, 743, and 734, respectively), mostly in rheumatoid arthritis. Proposed biosimilars for adalimumab, etanercept, infliximab, and rituximab are reported in the published literature. Intended copies were differentiated as commercially available agents without evidence of rigorous comparative biosimilarity evaluations. Studies disclosing biosimilars with unique identifiers were categorized by originator, study type, and indication. Selected conference proceedings were searched from 2012 to July 2015.
MEDLINE(®), EMBASE(®), and ISI Web of Science(®) were searched to September 2015.
The objective of this study was to systematically collate all published data in order to assess the weight (quantity and quality) of available evidence for each molecule and inform and support healthcare decision-making in chronic inflammatory diseases. In this review the in vitro and in vivo models used for the assessment of proposed biosimilars will be discussed.Ĭlinicians are required to assimilate, critically evaluate, and extrapolate information to support appropriate use of biosimilars across indications. However, the demonstration of comparability at physicochemical, preclinical, and clinical levels is required in order to achieve market registration. For this reason, the evaluation of biosimilar drugs has acquired great relevance, being the preclinical level of one of the more important stages of the development due to its lower cost (with respect to the clinical level) and its high capacity to detect formulation-manufacture problems. In fact, certain variability has been detected of the protein properties in different lots (or batches) of the same manufacturer, which produce changes at a clinical level. It has suggested that due to the complex implications in a formulation containing a protein, the manufacturing process is a key factor for efficacy and safety requirements. Many of these contains a similar active principle (biosimilar drug) as other previously registered (innovator drug). There are currently over 300 biopharmaceuticals worldwide.
A drug that contains a recombinant protein as an active principle is called a biotechnological drug or biopharmaceutical.
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