Abstract：
:Challenges in demonstrating interchangeability and safety, as well as the ongoing evolution of regulations governing biosimilars, have meant that the development of the biosimilars industry has not been, and will not be, a carbon copy of the generics industry. Complexity in the development process reduces the cost advantages for biosimilars that generics offer over originators. There has been a marked difference in the number of biosimilars approved by the European Medicines Agency (EMA) and US FDA due to a lack of consensus and the different rates of progress in establishing both law and stable evidence-based regulatory guidelines for biosimilars. In this review, we provide a précis of the history and status of the regulatory regimes in the USA and Europe. Included is an assessment of market and nonmarket factors that may continue to influence the development of the biosimilars industry.
journal_name
Trends Biotechnoljournal_title
Trends in biotechnologyauthors
Konara CS,Barnard RT,Hine D,Siegel E,Ferro Vdoi
10.1016/j.tibtech.2015.10.009subject
Has Abstractpub_date
2016-01-01 00:00:00pages
70-83issue
1eissn
0167-7799issn
1879-3096pii
S0167-7799(15)00227-9journal_volume
34pub_type
杂志文章,评审abstract：:Cloning of the cystic fibrosis (CF) gene and elucidation of the physiological functions of the encoded protein is a triumph, not only for molecular biology, but also for people affected by CF. For them, not only is there now the possibility of screening for the commonest mutations, but they may also look forward to th...
journal_title：Trends in biotechnology
pub_type： 杂志文章,评审
doi：10.1016/0167-7799(91)90188-N
更新日期：1991-02-01 00:00:00
abstract：:Small interfering RNAs (siRNAs) have been shown to effectively downregulate gene expression in human cells, giving them potential to eradicate disease. Prospects for clinical applications are discussed in this review, along with an overview of recent history and our current understanding of siRNAs used for therapeutic...
journal_title：Trends in biotechnology
pub_type： 杂志文章,评审
doi：10.1016/j.tibtech.2010.07.009
更新日期：2010-11-01 00:00:00
abstract：:The use of antibodies or antibody fragments for targeting tumors (either for tumor imaging or as carriers for drugs or toxins), has encountered problems of clearance, and non-specific or inefficient binding in clinical trials. A novel approach, linking two antibody variable fragments (Fvs), with a short peptide to gen...
journal_title：Trends in biotechnology
pub_type： 杂志文章,评审
doi：10.1016/0167-7799(91)90044-i
更新日期：1991-04-01 00:00:00
abstract：:Although many microorganisms have been used for the bioindustrial generation of valuable metabolites, the productive potential of cyanobacterial species has remained largely unexplored. Cyanobacteria possess several advantages as organisms for bioindustrial processes, including simple input requirements, tolerance of ...
journal_title：Trends in biotechnology
pub_type： 杂志文章,评审
doi：10.1016/j.tibtech.2010.12.003
更新日期：2011-02-01 00:00:00
abstract：:We review published data on cell/gamete lyophilization. Most studies have utilized the same established protocols for cryopreservation (storage in liquid nitrogen) as for cell lyophilization (dehydration of frozen samples by water sublimation). Surveying natural lyoprotectants, we suggest trehalose and late embryogene...
journal_title：Trends in biotechnology
pub_type： 杂志文章,评审
doi：10.1016/j.tibtech.2013.09.004
更新日期：2013-12-01 00:00:00
abstract：:A key aspect of the genomics revolution is the transformation of large amounts of biological information into an electronic format, leading to an information-based approach to biomedical problems. Large-scale RNA assays and gene-expression-microarray studies, in particular, represent the second wave of the genomics re...
journal_title：Trends in biotechnology
pub_type： 杂志文章,评审
doi：10.1016/s0167-7799(99)01359-1
更新日期：1999-11-01 00:00:00
abstract：:Rice is the staple diet of more than three billion people. Yields must double over the next 40 years if we are to sustain the nutritional needs of the ever-expanding global population. Between 10% and 30% of the annual rice harvest is lost due to infection by the rice blast fungus Magnaporthe oryzae. Evaluation of gen...
journal_title：Trends in biotechnology
pub_type： 杂志文章,评审
doi：10.1016/j.tibtech.2008.12.002
更新日期：2009-03-01 00:00:00
abstract：:The bioeconomy concept is proliferating globally. However, the enabling roles of biotechnology may be getting sidelined in the strategies of some countries. A goal for engineering biology is alignment with the engineering design cycle to enable more rapid commercialization. This paper considers several policy options ...
journal_title：Trends in biotechnology
pub_type： 杂志文章
doi：10.1016/j.tibtech.2019.03.017
更新日期：2019-09-01 00:00:00
abstract：:The effective management of emerging insect-borne disease is dependent on the use of safe and efficacious chemical insecticides. Given the inherent ability of insects to develop resistance, it is essential to propose innovative strategies because insecticides remain the most important element of integrated approaches ...
journal_title：Trends in biotechnology
pub_type： 杂志文章
doi：10.1016/j.tibtech.2008.12.005
更新日期：2009-04-01 00:00:00
abstract：:Along with the great strides that have been made towards understanding cancer, has come a realization of the complexity of molecular events that lead to malignancy. Proteomics-based approaches, which enable the quantitative investigation of both cellular protein expression levels and protein-protein interactions invol...
journal_title：Trends in biotechnology
pub_type： 杂志文章,评审
doi：10.1016/S0167-7799(01)01801-7
更新日期：2001-10-01 00:00:00
abstract：:Proteins found in nature have traditionally been the most frequently used biocatalysts to produce numerous natural products ranging from commodity chemicals to pharmaceuticals. Protein engineering has emerged as a powerful biotechnological toolbox in the development of metabolic engineering, particularly for the biosy...
journal_title：Trends in biotechnology
pub_type： 杂志文章,评审
doi：10.1016/j.tibtech.2019.12.008
更新日期：2020-07-01 00:00:00
abstract：:Lyases catalyse the cleavage of C-C, C-N, C-O and other bonds by elimination to produce double bonds or, conversely, catalyse the addition of groups to double bonds. These enzymes do not require cofactor recycling, show an absolute stereospecificity and can give a theoretical yield of 100%, compared with only 50% for ...
journal_title：Trends in biotechnology
pub_type： 杂志文章,评审
doi：10.1016/0167-7799(94)90112-0
更新日期：1994-03-01 00:00:00
abstract：:The well-studied antigen-combining sites of antibody molecules hold considerable promise as a model system for the design of bioactive peptides. These small, immunoglobulin-derived peptides can be used in the development of alternative treatments for disease and in diagnostic strategies. The general principles derived...
journal_title：Trends in biotechnology
pub_type： 杂志文章,评审
doi：10.1016/0167-7799(94)90038-8
更新日期：1994-09-01 00:00:00
abstract：:In 2006, the group of Dr C.M. Lieber pioneered the field of nanowire sensors by fabricating devices for the ultra-sensitive label-free detection of biological macromolecules. Since then, nanowire sensors have demonstrated their ability to detect cancer-associated analytes in peripheral blood, tumor tissue, and the exh...
journal_title：Trends in biotechnology
pub_type： 杂志文章,评审
doi：10.1016/j.tibtech.2018.07.014
更新日期：2019-01-01 00:00:00
abstract：:Although microorganisms have long been known as producers of edible oils, opportunities for their biotechnological exploitation are limited to the highest-value commodities. A recent attempt to develop a yeast oil cocoa-butter equivalent has not succeeded, not because of the inability to produce the correct formulatio...
journal_title：Trends in biotechnology
pub_type： 杂志文章
doi：10.1016/0167-7799(93)90015-2
更新日期：1993-07-01 00:00:00
abstract：:Since its invention at the beginning of the 1990s, antibody phage display has revolutionized the generation of monoclonal antibodies and their engineering. It is now possible to create antibodies binding to any chosen target antigen without the use of laboratory animals or hybridomas, in a system that completely by-pa...
journal_title：Trends in biotechnology
pub_type： 杂志文章,评审
doi：10.1016/S0167-7799(97)84205-9
更新日期：1997-02-01 00:00:00
abstract：:Small molecules are defined as low molecular weight organic compounds (typically <1000 Da), which could be either natural or artificial. Because established imaging methods are not able to selectively detect the positions, concentrations and structures of small molecules in biological samples, new methods have been de...
journal_title：Trends in biotechnology
pub_type： 杂志文章,评审
doi：10.1016/j.tibtech.2010.05.005
更新日期：2010-08-01 00:00:00
abstract：:The field of regenerative medicine has blossomed in recent decades. However, the ultimate goal of tissue regeneration - replacing damaged or aged cells with healthy functioning cells - still faces a number of challenges. In particular, better understanding of the role of the cellular niche in shaping stem cell phenoty...
journal_title：Trends in biotechnology
pub_type： 杂志文章,评审
doi：10.1016/j.tibtech.2019.01.005
更新日期：2019-07-01 00:00:00
abstract：:With the ultimate aim to construct a living cell, bottom-up synthetic biology strives to reconstitute cellular phenomena in vitro - disentangled from the complex environment of a cell. Recent work towards this ambitious goal has provided new insights into the mechanisms governing life. With the fast-growing library of...
journal_title：Trends in biotechnology
pub_type： 杂志文章,评审
doi：10.1016/j.tibtech.2018.03.008
更新日期：2018-09-01 00:00:00
abstract：:Bacteriophages encode many distinct proteins for the successful infection of a bacterial host. Each protein plays a specific role in the phage replication cycle, from host recognition, through takeover of the host machinery, and up to cell lysis for progeny release. As the roles of these proteins are being revealed, m...
journal_title：Trends in biotechnology
pub_type： 杂志文章,评审
doi：10.1016/j.tibtech.2018.04.006
更新日期：2018-09-01 00:00:00
abstract：:The drive for industrial sustainability has pushed biosurfactants to the top of the agenda of many companies. Biosurfactants offer the possibility of replacing chemical surfactants, produced from nonrenewable resources, with alternatives produced from cheap renewable feedstocks. Biosurfactants are also attractive beca...
journal_title：Trends in biotechnology
pub_type： 杂志文章,评审
doi：10.1016/j.tibtech.2012.07.003
更新日期：2012-11-01 00:00:00
abstract：:Integrated biorefineries have the potential to contribute towards sustainable production of transportation fuels, energy, and chemicals. However, because there are currently no commercial biorefining plants in operation, it is not clear how sustainable they really are. This paper sets out to examine key issues associa...
journal_title：Trends in biotechnology
pub_type： 杂志文章
doi：10.1016/j.tibtech.2013.10.009
更新日期：2014-01-01 00:00:00
abstract：:Acidity is a biomarker of cancer that is not subject to the blunting clonal selection effects that reduce the efficacy of other biomarker technologies, such as antibody targeting. The pH (low) insertion peptides (pHLIP®s) provide new opportunities for targeting acidic tissues. Through the physical mechanism of membran...
journal_title：Trends in biotechnology
pub_type： 杂志文章,评审
doi：10.1016/j.tibtech.2017.03.014
更新日期：2017-07-01 00:00:00
abstract：:The generation of genetically engineered (GE) foods has been raising several concerns and controversies that divide not only the general public but also the scientific community. The fear and importance of the new technology, as well as commercial interests, have supported many of the ongoing discussions. The recent i...
journal_title：Trends in biotechnology
pub_type： 杂志文章,评审
doi：10.1016/j.tibtech.2009.01.005
更新日期：2009-05-01 00:00:00
abstract：:Colloidal gas aphrons are microbubbles encapsulated by surfactant multilayers. They provide a large interfacial area to adsorb charged and/or hydrophobic molecules; the extent and mechanism of the adsorption depends on the surfactant multilayer. The physical properties of colloidal gas aphrons have recently been chara...
journal_title：Trends in biotechnology
pub_type： 杂志文章
doi：10.1016/s0167-7799(99)01363-3
更新日期：1999-10-01 00:00:00
abstract：:The promising recognition characteristics exhibited by biomolecules have caused significant interest in biomolecule-based sensor strategies. Here we review several emerging biosensor designs that use modulated electron or energy transfer to a bio-specific ligand as the signaling mechanism. The efficiencies of both ele...
journal_title：Trends in biotechnology
pub_type： 杂志文章,评审
doi：10.1016/j.tibtech.2005.02.005
更新日期：2005-04-01 00:00:00
abstract：:Microfluidic devices offer automation and high-throughput screening, and operate at low volumes of consumables. Although microfluidics has the potential to reduce turnaround times and costs for analytical devices, particularly in medical, veterinary, and environmental sciences, this enabling technology has had limited...
journal_title：Trends in biotechnology
pub_type： 杂志文章
doi：10.1016/j.tibtech.2014.04.010
更新日期：2014-07-01 00:00:00
abstract：:The development of yeast artificial chromosome (YAC) cloning vectors capable of carrying several hundred kilobase-pairs of DNA insert has greatly facilitated the study of complex genomes, and the cloning of large genes as single fragments. In addition, the ability to manipulate YAC sequences by homologous recombinatio...
journal_title：Trends in biotechnology
pub_type： 杂志文章,评审
doi：10.1016/0167-7799(92)90165-r
更新日期：1992-01-01 00:00:00
abstract：:Cyclodextrins, macrocyclic carbohydrates with apolar internal cavities, can form complexes with, and solubilize many normally water-insoluble compounds. Ferrocene and its derivatives, tetrathiafulvalene and tetramethylbenzidine, can function as redox mediators, but are insoluble in water; when they are complexed with ...
journal_title：Trends in biotechnology
pub_type： 杂志文章,评审
doi：10.1016/S0167-7799(00)89002-2
更新日期：1995-11-01 00:00:00
abstract：:Peptide nucleic acids (PNAs) are novel DNA mimics in which the sugar-phosphate backbone has been replaced with a backbone based on amino acids. PNAs exhibit sequence-specific binding to DNA and RNA with higher affinities and specificities than unmodified DNA. They are resistant to nuclease and protease attack in serum...
journal_title：Trends in biotechnology
pub_type： 杂志文章
doi：10.1016/0167-7799(93)90097-S
更新日期：1993-09-01 00:00:00
