Current Issue : January - March Volume : 2014 Issue Number : 1 Articles : 4 Articles
From 2006 to 2011, an average of 15 novel recombinant protein therapeutics\r\nhave been approved by US Food and Drug Administration (FDA) annually. In addition, the\r\nexpiration of blockbuster biologics has also spurred the emergence of biosimilars. The\r\nincreasing numbers of innovator biologic products and biosimilars have thus fuelled the\r\ndemand of production cell lines with high productivity. Currently, mammalian cell line\r\ndevelopment technologies used by most biopharmaceutical companies are based on either\r\nthe methotrexate (MTX) amplification technology or the glutamine synthetase (GS)\r\nsystem. With both systems, the cell clones obtained are highly heterogeneous, as a result of\r\nrandom genome integration by the gene of interest and the gene amplification process.\r\nConsequently, large numbers of cell clones have to be screened to identify rare stable high\r\nproducer cell clones. As such, the cell line development process typically requires 6 to 12\r\nmonths and is a time, capital and labour intensive process. This article reviews established\r\nadvances in protein expression and clone screening which are the core technologies in\r\nmammalian cell line development. Advancements in these component technologies are\r\nvital to improve the speed and efficiency of generating robust and highly productive cell\r\nline for large scale production of protein therapeutics....
According to the World Health Organization (WHO), one third of the world�s population don�t have the necessary\r\naccess to pharmaceutical products, including essential drugs. In Brazil, the Governmental Health System (SUS)\r\ndistributes some medicaments for free to the population. They were, then, classified into three categories in the\r\ncountry: basic, strategic and specialized components. Among these categories, the last one is highlighted due\r\nto the expensive costs of its products, which are essential for the treatment of rare and specific diseases. For\r\nthis reason, the Ministry of Health created, in 1993, the Program for Specialized Medicaments, where all the\r\ndrugs included in this category were distributed for free through Clinics and Hospitals. During the first year of this\r\nProgram�s implementation, there were 15 different items distributed into 31 distinct presentations. Nowadays, the list\r\nexpanded to 150 different items dispensed into 310 presentations. Hence, the availability of imported pharmaceutical\r\nproducts in Brazil overloaded the expenses by the Brazilian Ministry of Health. Only during 2011, US$ 1.5 billion\r\nwere spent on these products, where 30% of this amount was related to specialized ones. In order to reduce costs,\r\nthe Brazilian Federal Government developed, in 2004, the Technological Innovation Law. According to the Decree\r\nnumber 6.041, the National Politics for Biotechnology and the National Committee of Biotechnology were created\r\nin order to stimulate the development of Biotechnology for human health, targeting mainly the national production\r\nof biopharmaceuticals. Furthermore, the end of patents for several medicaments during the last 5 years enhanced\r\nthe motivation for national production of new drugs. In this way, some Governmental Institutions, in partnership\r\nwith International Pharmaceutical Industries, started developing the first biosimilar molecules. Therefore, this report\r\ndescribes the evolution of Biotechnology in Brazil, relating the laws, regulations and Programs created along the last\r\n20 years for Human Health application....
Background: Chemotherapy-induced anaemia is a common and significant complication of chemotherapy\r\ntreatment. Blood transfusion and administration of Erythropoiesis-Stimulating Agents (ESAs) either alone or in\r\ncombination with iron are the most widely used therapeutic options. In Greece, ESAs are among the top ten\r\ntherapeutic groups with the highest pharmaceutical expenditure, since they are fully reimbursed by social security\r\nfunds. The objective of the study is to determine potential cost savings related with the use of biosimilar over\r\noriginator ESAs for the management of the newly diagnosed chemotherapy-induced anemic patients.\r\nMethods: A budget impact analysis has been carried through the elaboration of national epidemiological, clinical\r\nand economic data. Epidemiological data derived from WHO (GLOBOCAN) and the European Cancer Anaemia\r\nSurvey. Clinical data reflect oncology patientsââ?¬â?¢ disease management. ESAs consumption was based on data from\r\nthe biggest social security fund (IKA). The administration of ESAs under different dosing schemes and time periods\r\nhas been estimated by separating them in originators and biosimilars as well as by classifying anaemic patients in\r\nresponders and non-responders. Cost analysis is based on newly diagnosed patientsââ?¬â?¢ alternative treatment\r\nscenarios. Treatment costs and prices are used in 2012 values. The Social Security Fundsââ?¬â?¢s perspective was\r\nundertaken.\r\nResults: Based on the annual incidence rates, 2.551 newly diagnosed chemotherapy-induced anemic patients are\r\nexpected to be treated with ESAs. Average cost of treatment on originators ESAs for responders is ââ??¬2.887 for the\r\n15-week ESAs treatment and ââ??¬5.019 for non-responders, while on biosimilars ââ??¬2.623 and ââ??¬4.009 respectively.\r\nTreatment cost on biosimilars is 10.1% lower than originators for responders and 25.2% for non-responders. Budget\r\nimpact estimates show that treating anemic patients with originator ESAs was estimated at ââ??¬10.084.800 compared\r\nto ââ??¬8.460.119 when biosimilar ESAs were used, leading to an overall 19,20% cost reduction favoring biosimilars.\r\nConclusion: In Greece, the treatment on biosimilar ESAs seems to be a cost saving option over originators for the\r\nnewly diagnosed chemotherapy-induced anemic patients, since it corresponds to 5% of the annual overall\r\nconsumption and expands patientsââ?¬â?¢ access to ESAs treatment. Health care decision making should rely on evidence\r\nbased treatments in order to achieve social fundsââ?¬â?¢ sustainability in an era of economic recession....
More and more biopharmaceutical and/or biotech companies begin to concern regulatory approval of biosimilar products, due to some innovator products will expire in decades. Once more biological products are going off patient, the problem whether approving biosimilar products used interchangeably and safely will be considered. Using a biological product of the reference product interchangeably, the United States Food and Drug Administration (FDA) requires that, for a biological product that is administered more than once to an individual, the risk in terms of safety or diminished efficacy of alternating or switching between the use of the biological product and the reference product, is not greater than the risk of using the reference product without such alternation or switch. For this purpose, based on the concept of switching and/or alternation several useful designs for assessing drug interchangeability are proposed. In addition, by developed biosimilarity index, a uni?ed approach is discussed. The proposed method is robust against biosimilarity criteria and is applicable under a valid and appropriate study design....
Loading....