By Sarfaraz K. Niazi
What’s the care for Biosimilars?
Biosimilars are gaining momentum as new protein healing applicants which may support fill a necessary desire within the healthcare undefined. The organic medications are produced through recombinant DNA know-how that enables for large-scale creation and an total aid time in charges and improvement.
Part of a two-volume set that covers various features of biosimilars, Biosimilars and Interchangeable Biologics: Strategic components explores the strategic making plans part of biosimilar medications and goals matters surrounding biosimilars which are associated with criminal issues. This comprises central patents and highbrow estate, regulatory pathways, and issues approximately affordability on a world scale. It addresses the complexity of biosimilar items, and it discusses the usage of biosimilars and comparable organic medications in increasing global markets.
Of particular curiosity to practitioners, researchers, and scientists within the biopharmaceutical undefined, this quantity examines the technology, expertise, finance, legality, ethics, and politics of biosimilar medications. It considers strategic making plans parts that come with an total knowing of the heritage and the present prestige of the artwork and technological know-how of biosimilars, and it presents unique descriptions of the felony, regulatory, and advertisement features. The ebook additionally offers an international approach on how one can construct, take to marketplace, and deal with the following new release of biosimilars all through their existence cycle.
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Extra info for Biosimilar and Interchangeable Biologics: Strategic Elements
Sample text
Smith and James T. , Lahore, Pakistan, 2010 • Disposable Bioprocessing Systems, CRC Press, Boca Raton, FL, 2012 xliv Author • Handbook of Bioequivalence Testing, Second Edition, Informa Healthcare, New York, NY, 2014 • There Is No Wisdom: Selected Love Poems of Bedil. Translations from Darri Farsi, Sarfaraz K. Niazi and Maryam Tawoosi, Ferozsons Private (Ltd), Lahore, Pakistan, 2015 • Biosimilars and Interchangeable Biologicals: Strategic Elements, CRC Press, 2015 • Biosimilars and Interchangeable Biologics: Tactical Elements, CRC Press, 2015 • Fundamentals of Modern Bioprocessing, Sarfaraz K.
The issue of naming is a hot topic and remains unresolved in the United States. Partial relief came with the approval of the first biosimilar in United States, wherein the FDA took a middle road, and instead of using the INN name, they suggested using a qualified INN, the generic name attached to an abbreviated identification of the developer. In this case, Sandoz’s filgrastim was given the name filgrastim-sndz. This disappointed many, but the FDA said that this is a placeholder arrangement and final guidance will come in due course.
FDA; there is no interchangeable status in Europe. S. and European perspectives and the naming controversy, whether to give this product the generic name (INN) or a brand name is explored, and the positions of major agencies in Europe, World Health Organization, and the United States are contrasted. This chapter provides an overview of the manufacturing systems used for biosimilar products and their characterization techniques, the most important aspects of developing these products. An overall view of global regulatory approval pathways is described with emphasis on the focus of the approval strategy, providing examples of how the European Medicine Agency (EMA) deals with these situations, more particularly in the light of recent changes at EMA that bring it closer to the United States in its approval strategy.