Current Issue : January - March Volume : 2016 Issue Number : 1 Articles : 4 Articles
Therapeutics derived through application of modern biotechnology has become an essential component of contemporary pharmacology and clinical medicine. Biopharmaceuticals have given an unprecedented edge to humanity to treat many formidable diseases. It has been anticipated that biotechnological medicines will occupy 50% share of pharmaceutical market by next decade. The first ever biotech drug came into use by the advent of recombinant insulin in early 80ââ?¬â?¢s. Since then many biologics including recombinant human protein and monoclonal antibodies followed that changed the world of therapeutics. All these came through years and years of intensive research and at the cost of huge investments. Now we are passing through a time when some of the biologics have lost patent protection and many are moving towards it. ââ?¬Å?Patent Cliffââ?¬Â is a well noticed term nowadays in biopharmaceutical industry that opened the scope for ââ?¬Å?biosimilarsââ?¬Â entry into therapeutic market. This simply means that the expiry of patent protection for many original biopharmaceuticals or biologics has led to the development of newer versions of original products. These similar products are called ââ?¬Å?biosimilarsââ?¬Â or ââ?¬Å?non-original biologicsââ?¬Â. Biosimilars are also innovative biotechnology medicines but copy the original technology to obtain a therapeutic what is similar to the original one. However, there might be differences on a protein level depending on the biological process of manufacturing. Biosimilars represent the newer class of biotech medicinal products that have been anticipated to have significant impact on therapeutics market. Biosimilars development is currently one of the fastest growing areas in biopharmaceuticals industry because of incumbent patent expiry of top 12 best-selling biologics. In June 2013, worldââ?¬â?¢s first biosimilar of infliximab, RemsimaÃ?® (CT-P13) developed by Celltrion, was approved by the Committee for Medicinal Products for Human Use (CHMP) of European Medicine Agency (EMA). Many more biosimilars are in the pipeline and some are awaiting approval. Biosimilar approval has evoked a competition in global market targeting the blockbuster biologics. The underlying reason is that biosimilars will dramatically reduce the cost of treatments where biologics are predominating. Moreover, a recent advance in technology in biopharmaceutical industry allows showing similarity between originator and biosimilar product. Although biosimilars are emerging in the market and their market share is increasing although there are many issues raising the concerns such as safety, immunogenicity, regulatory processes, pharmacovigilance, automatic substitution, naming and labelling rules. Recent evidences have been able to demonstrate quality, efficacy, and safety of biosimilars whereas a lack of interchangeability and international standards has to be addressed. Here we provide a brief overview of biosimilars development, its increasing uses and market value as well as opportunities for emerging pharmaceutical industries....
In order to appropriately support the equivalence between a biosimilar and the referenced biopharmaceutical it is essential to carry out equivalence or non-inferiority clinical studies. The objective of this paper was to study the therapeutic bioequivalence of IFN Ã?²-1A biosimilar vs. IFN Ã?²-1A innovator. The efficacy and safety of these drugs was assessed in Mexican patients under treatment for relapsing-remitting multiple sclerosis (RRMS). A parallel, multicenter, prospective and comparative study was carried out. Fifty patients with confirmed RRMS were studied. The following parameters were considered for the diagnosis of confirmed RRMS: Magnetic Resonance Imaging (MRI) demonstrating demyelinating lesions; expanded disability status scale (EDSS) scores between 0 ââ?¬â?? 5.5; and McDonaldââ?¬â?¢s criteria compatible with MS. Patients were randomly divided into 2 groups of 25 patients each. Patients from the first group were treated with Avonex Ã?®, 30 mg-per-week. Patients from the second group were treated with AxuarebÃ?® at the same dose. All patients were followed for a period of 24 months. Forty-five patients (90%) out of the initially recruited 50 patients completed the follow-up period. Annual relapse rates were 11% and 8% for Avonex and Axuareb, respectively. The proportions of relapse-free, improvement and detriment showed non-significant differences (p>0.05) between groups. The incidence of side effects showed a non-significant difference (p>0.05) between groups. SF-36 data of physical and mental status demonstrated non-significant differences between groups after the follow-up period. Although, MRI findings demonstrated a significant increase (p<0.05) in the number of demyelinating lesions after the follow-up period in both groups of patients, the group of patients treated with Axuareb demonstrated a significantly reduced mean number of lesions after the follow-up period. In conclusion, both drugs showed similar effectiveness and safety. Thus, from the results of this clinical trial, it seems that Axuareb, a biosimilar IFN is a safe and reliable alternative for treating patients with MS....
and are in clinical use for a number of diseases. Recently, the expiry of many of these product patents led to the\ndevelopment of other non-innovator similar biologics at lower costs, having the same safety, purity and potency as\ntheir original counterparts. These non-innovator similar biologics are generally referred to as biosimilars.\nBiosimilars are produced in living organisms by recombinant DNA techniques and exploiting the cellular\nmechanisms of the host so, there could be some differences at the molecular level due to their complex\nnature. Henceforth, they have to face numerous challenges for their development and approval, including the\ncomplex manufacturing process, immunogenicity issues, nomenclature, extrapolation of different indications,\ninterchangeability with their originators, awareness amongst the clinicians and patients and the costs of production\nfor the manufacturers.\n\n \n \n \n\n\n \n \n \n\n \n \n \nconcerns, indeed the standard generic approach is not applicable to demonstrate similarity between a biosimilar\nand its reference product. So, many Regulatory Authorities have established guidelines for the development and\napproval of biosimilars.\nBiosimilars are an essential product category that makes biological drugs available to different markets at an\naffordable cost. Their use is ought to increase in the upcoming years as per the demand and supply of these drugs is\nconcerned. Hence, aim of this review is to discuss the problems surrounding the biosimilars and to give an overview\non their regulatory statuses across the world. Concluding, we believe that to achieve a balance between drug quality,\nsafety and the population health needs, a profound knowledge of biosimilar development as well as joint effort of the\nmanufacturers and their will to share the critical development data, is needed....
Specific inhibition of the cytokine, tumor necrosis factor-Ã?± (TNF), has revolutionized the\ntreatment of patients with several autoimmune diseases, and genetically engineered anti-\nTNF antibody constructs now constitute a heavy medicinal expenditure in many countries.\nUnfortunately, up to 30% of patients do not respond and about 50% of those who do\nloose response with time. Furthermore, safety may be compromised by immunogenicity\nwith the induction of anti-drug-antibodies (ADA). Assessment of drug pharmacokinetics\nand ADA is increasingly recognized as a requirement for safe and rational use of protein\ndrugs.The use of therapeutic strategies based on anti-TNF drug levels and ADA rather than\ndose-escalation has also proven to be cost-effective, as this allows individualized patient tailored\nstrategies rather than the current universal approach to loss of response. The\nobjective of the present article ââ?¬â?? and the accompanying article ââ?¬â?? is to discuss the reasons\nfor recommending assessments of circulating drug and ADA levels in patients treated with\nanti-TNF biopharmaceuticals and to detail some of the methodological issues that obscure\ncost-effective and safer therapies....
Loading....