Results 271 to 280 of about 30,003 (287)
Anforderungen an Biosimilars und biosimilares Insulin [PDF]
Diabetologie und Stoffwechsel, 2015 Das erste biosimilare Insulin wurde in der Europaischen Union (EU) im September 2014 zugelassen, und in naher Zukunft werden wahrscheinlich weitere biosimilare Insuline folgen. In der EU steht der Begriff Biosimilar fur ein Nachfolgeprodukt eines Biopharmazeutikums.
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Journal of the National Comprehensive Cancer Network, 2016
As biologics go off-patent, the field of oncology is grappling with incorporating biosimilars. These are highly similar (but not generic versions of) biologic agents, and they are approved based on showing "near fingerprint identity" in structure and potency. Their introduction is expected to increase competition and lower treatment costs.
Pamela S. Becker, Andrew D. Zelenetz
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As biologics go off-patent, the field of oncology is grappling with incorporating biosimilars. These are highly similar (but not generic versions of) biologic agents, and they are approved based on showing "near fingerprint identity" in structure and potency. Their introduction is expected to increase competition and lower treatment costs.
Pamela S. Becker, Andrew D. Zelenetz
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Expert Review of Clinical Pharmacology, 2012
Recombinant biologics have had an incredible impact on diseases such as arthritis and cancer by targeting specific receptors or disease mediators; however, access to these drugs is increasingly lim...
Mark McCamish, Gillian R. Woollett
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Recombinant biologics have had an incredible impact on diseases such as arthritis and cancer by targeting specific receptors or disease mediators; however, access to these drugs is increasingly lim...
Mark McCamish, Gillian R. Woollett
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Seminars in Arthritis and Rheumatism, 2016
To provide an overview of the underlying scientific principles and standards for developing a biosimilar product.An Internet-based literature search through June 2015 was performed for information related to biosimilar manufacturing and development, including a review of regulatory guidelines and requirements.Biologics, both biosimilars and their ...
Ahmad AL-Sabbagh +3 more
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To provide an overview of the underlying scientific principles and standards for developing a biosimilar product.An Internet-based literature search through June 2015 was performed for information related to biosimilar manufacturing and development, including a review of regulatory guidelines and requirements.Biologics, both biosimilars and their ...
Ahmad AL-Sabbagh +3 more
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Journal of Proteomics, 2015
Biosimilars have been defined as biotech drugs that have been shown to have comparable quality, safety and efficacy to the original product. The past decade has seen a significant increase in interest in these products from the biotech industry. Major developments have occurred with respect to establishing a regulatory path for approval of these ...
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Biosimilars have been defined as biotech drugs that have been shown to have comparable quality, safety and efficacy to the original product. The past decade has seen a significant increase in interest in these products from the biotech industry. Major developments have occurred with respect to establishing a regulatory path for approval of these ...
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Biosimilars: Are They Bioequivalent?
Digestive Diseases, 2014Biologics have revolutionized several areas of medical therapeutics, and dozens of them are used by millions of patients. Monoclonal antibodies are only one type of biologics, but more than 900 are now in different phases of development. These drugs are complex to make and not cheap.
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Expert Opinion on Therapeutic Patents, 2016
This paper explores whether, and under what circumstances, a biosimilar approved in the United States under the Biologics Price Competition and Innovation Act (hereafter 'BPCIA') can be patented. The possibility that a biosimilar product could have meaningful patent protection arises from specific requirements for biosimilarity under the BPCIA, which ...
Max Morgan +2 more
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This paper explores whether, and under what circumstances, a biosimilar approved in the United States under the Biologics Price Competition and Innovation Act (hereafter 'BPCIA') can be patented. The possibility that a biosimilar product could have meaningful patent protection arises from specific requirements for biosimilarity under the BPCIA, which ...
Max Morgan +2 more
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European Journal of Hospital Pharmacy, 2019
Biological medicines have become indispensable in the treatment of patients with serious diseases such as cancer and inflammatory diseases. Biosimilars are medicines which are developed to be similar to existing biological medicines (the 'reference product'). For the European market, they are approved by the European Medicines Agency.
András Süle +4 more
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Biological medicines have become indispensable in the treatment of patients with serious diseases such as cancer and inflammatory diseases. Biosimilars are medicines which are developed to be similar to existing biological medicines (the 'reference product'). For the European market, they are approved by the European Medicines Agency.
András Süle +4 more
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Biosimilars 101: An Introduction to Biosimilars
2018The surging costs of biological medicines worldwide have necessitated the development of biosimilars. These highly similar versions of off-patent biological products entered the EU in 2006 and the U.S. in 2015. Unlike small molecule generic drugs, which are chemically identical to their originator products, biosimilar products cannot be identical ...
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Biosimilars in allergic diseases
Current Opinion in Allergy & Clinical Immunology, 2016This article realizes an overview on the world of biological and biosimilar drugs in allergic and immunologic diseases' treatment strategies. We started talking about the history of asthma treatment's progresses, continuing to daily biological therapies, concluding with the economic point of view.Nowadays, the only pharmacological-biological approach ...
FERRANDO, MATTEO +4 more
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