Download Biosimilar and Interchangeable Biologics: Strategic Elements by Sarfaraz K. Niazi PDF

By Sarfaraz K. Niazi

What’s the care for Biosimilars?

Biosimilars are gaining momentum as new protein healing applicants that may support fill an essential want within the healthcare undefined. The organic medicinal drugs are produced through recombinant DNA expertise that enables for large-scale creation and an total aid time in charges and improvement.

Part of a two-volume set that covers various facets of biosimilars, Biosimilars and Interchangeable Biologics: Strategic parts explores the strategic making plans aspect of biosimilar medications and pursuits matters surrounding biosimilars which are associated with felony issues. This contains central patents and highbrow estate, regulatory pathways, and matters approximately affordability on a world scale. It addresses the complexity of biosimilar items, and it discusses the usage of biosimilars and comparable organic medicinal drugs in increasing global markets.

Of particular curiosity to practitioners, researchers, and scientists within the biopharmaceutical undefined, this quantity examines the technological know-how, expertise, finance, legality, ethics, and politics of biosimilar medicinal drugs. It considers strategic making plans parts that come with an total realizing of the historical past and the present prestige of the artwork and technology of biosimilars, and it presents specified descriptions of the criminal, regulatory, and advertisement features. The e-book additionally provides a world process on tips on how to construct, take to industry, and deal with the following new release of biosimilars all through their lifestyles cycle.

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Historically, mergers between pharmaceutical and biopharmaceutical companies have not fared well. Where the surviving company is the pharmaceutical company, it creates difficulty in understanding the elaborate nature of production techniques. Where the biopharmaceutical company survives the merger, the problems have been the visualization beyond the research horizon and translating the bioprocess into a commercially feasible validated process. In my opinion, the best solutions are offered through outsourcing, as the technical requirements are highly complex and elaborate to manufacture these products.

The unfortunate part of this dichotomy is the risk to patients if these products fail to meet the quality standards required to assure their safety. Given the technical difficulties inherent in the development of biosimilars, a product developed and distributed hastily at a rock-bottom price shall always remain suspect for its quality. One of the main purposes of this book is to make the manufacturers of these products aware of this risk and offer solutions that will be helpful in improving the quality of their products.

Patent Office. A barrage of patents appear just when the composition patents are about to expire; many of these patents will be challenged, and some will be declared invalid. However, this practice, which involves every step of bioprocessing, formulation, and even dosing, creates an environment of uncertainty among biosimilar developers. Some consider this practice to be unethical, if not entirely illegal. About regulatory approvals Europe has taken the lead in introducing biosimilar product guidelines and ­approvals, and one country in particular, France, has even legislated their interchangeable status for use in new patients.

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