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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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Expert Opinion on Biological Therapy, 2012
Until now most insulin used in developed countries is manufactured and distributed by a small number of multinational companies. Other pharmaceutical companies - many of these are located in countries such as India or China - are also able to manufacture insulin with modern biotechnological methods.
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Until now most insulin used in developed countries is manufactured and distributed by a small number of multinational companies. Other pharmaceutical companies - many of these are located in countries such as India or China - are also able to manufacture insulin with modern biotechnological methods.
openaire +2 more sources
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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Anforderungen an Biosimilars und biosimilares Insulin
Diabetologie und Stoffwechsel, 2015Das 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.
E. Mönnig +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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2017
Biosimilars are a new class of drugs, which are derived from live organism through the recombinant DNA technology. These are recently introduced in the pharmaceutical field for the preparation of drug to prevent or control the diseases. Patients with diabetes and renal failure may already be receiving biosimilar epoetin and may receive same insulin in ...
Anil K. Sharma +2 more
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Biosimilars are a new class of drugs, which are derived from live organism through the recombinant DNA technology. These are recently introduced in the pharmaceutical field for the preparation of drug to prevent or control the diseases. Patients with diabetes and renal failure may already be receiving biosimilar epoetin and may receive same insulin in ...
Anil K. Sharma +2 more
openaire +1 more source
Biosimilar anti-VEGF—Yardsticks to ensure biosimilarity
Eye, 2022Ashish Sharma +4 more
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Biosimilars accessible in the market for the treatment of cancer
Journal of Controlled Release, 2021Suryanarayana Polaka +2 more
exaly
Biosimilars. Was für Arzneimittel sind Biosimilars?
2019Kurzinformation für ...
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