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 which could aid fill a necessary want within the healthcare undefined. The organic medicines are produced by means of recombinant DNA know-how that permits for large-scale creation and an total aid time in expenditures and improvement.

Part of a two-volume set that covers various elements of biosimilars, Biosimilars and Interchangeable Biologics: Strategic parts explores the strategic making plans part of biosimilar medicinal drugs and objectives matters surrounding biosimilars which are associated with criminal concerns. This contains critical 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 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 figuring out of the historical past and the present prestige of the artwork and technological know-how of biosimilars, and it presents distinctive descriptions of the criminal, regulatory, and advertisement features. The publication additionally provides a world approach on easy methods to construct, take to marketplace, and deal with the subsequent iteration of biosimilars all through their existence cycle.

Show description

Read or Download Biosimilar and Interchangeable Biologics: Strategic Elements PDF

Similar biotechnology books

International Complete Collection of R&D Information About Traditional Chinese Materia Medica and Biotechnology Enterprises

The overseas whole choice of R&D information regarding conventional chinese language Materia Medica (TCMM) and Biotechnology (BT) organisations is designed as an informative medicinal reference listing directory of up to date R&D information regarding TCMM, clinical biotechnology, and similar scientific gear businesses.

Downstream Processing of Proteins: Methods and Protocols (Methods in Biotechnology)

Mohamed A. Desai and a staff of skilled biotechnologists evaluate either traditional and novel isolation thoughts utilized in commercial functions for the downstream processing of protein molecules. those suggestions contain fundamental and secondary separations through the isolation of biomolecules, in addition to certain laboratory-scale examine tools from academia with a possible for scale-up.

The Unique U.S.-Russian Relationship in Biological Science and Biotechnology: Recent Experience and Future Directions

Within the fall of 2010, the U. S. nationwide Academies (consisting of the nationwide Academy of Sciences, the nationwide Academy of Engineering, and the Institute of medication) and the Russian Academy of Sciences (in cooperation with the Russian Academy of scientific Sciences and the Russian Academy of Agricultural Sciences) initiated a joint learn of U.

Production of Biofuels and Chemicals with Ultrasound

Conversion of biomass into chemical substances and biofuels is an lively learn and improvement quarter as traits circulation to switch conventional fossil fuels with renewable assets. by way of integrating processing tools with ultrasound and microwave irradiation into biorefineries, the time-scale of many operations might be vastly diminished whereas the potency of the reactions should be remarkably elevated in order that procedure intensification should be accomplished.

Additional resources for Biosimilar and Interchangeable Biologics: Strategic Elements

Example text

Besides, analysts, who may well have a vested interest, keep talking about the percentage reduction in price and do not speak of the absolute value of savings given the very high price of these products. Currently, the savings in cost is more than 30% in Europe, and eventually a 50% reduction in cost is very likely. One aspect that is left out of the discussions is affordability. Because of their high cost, these products remain out of reach for many; lowered cost will significantly expand utilization of these products, and that will provide a significantly greater benefit to mankind.

Coca-Cola is an example of a pure play in this context because it retails only beverages. On the other hand, PepsiCo is not a pure play because it also owns the Frito-Lay snack foods brand. While there are several pure-play biotechnology companies, when it comes to pure-play biosimilar companies, the choice becomes limited in the developed countries; two names are prominent: Therapeutic Proteins International in United States and Celtrion in Korea. Outside of these, the choice of fully integrated pure-play companies is limited.

We can take a philosophic look at the category of drugs that are the copies of the molecules produced endogenously by the human body. The patent holders produced the first copies, and these were just copies of that are all what could be possibly produced. Once the patents expire, other companies get a chance to take a crack at these molecules, except that almost 20 years later, the technology available is more refined, both for manufacturing and analyzing these molecules. This puts the biosimilar product manufacturers at an advantage over the first licensed product manufacturer (often identified erroneously as the originators).

Download PDF sample

Rated 4.14 of 5 – based on 19 votes