Download Biosimilars and interchangeable biologics: strategic by Sarfaraz K. Niazi PDF

By Sarfaraz K. Niazi

What’s the take care of Biosimilars?

Biosimilars are gaining momentum as new protein healing applicants that could aid fill an important desire within the healthcare undefined. The organic medications are produced through recombinant DNA expertise that permits for large-scale construction and an total aid time in charges and improvement.

Part of a two-volume set that covers various elements of biosimilars, Biosimilars and Interchangeable Biologics: Strategic components explores the strategic making plans facet of biosimilar medicinal drugs and ambitions matters surrounding biosimilars which are associated with criminal issues. This contains crucial patents and highbrow estate, regulatory pathways, and matters approximately affordability on an international scale. It addresses the complexity of biosimilar items, and it discusses the usage of biosimilars and similar organic medicines 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 medicines. It considers strategic making plans parts that come with an total realizing of the historical past and the present prestige of the paintings and technological know-how of biosimilars, and it offers specific descriptions of the felony, regulatory, and advertisement features. The publication additionally provides a world technique on tips on how to construct, take to marketplace, and deal with the following iteration of biosimilars all through their existence cycle.

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Additional resources for Biosimilars and interchangeable biologics: strategic elements

Sample text

The concept of biosimilarity rather than bioequivalence emerged globally, and this terminology is now widely accepted, even though some agencies continue to promote “follow-on biologics,” “subsequent entry biologics” (SEBs), “biocomparables,” and other such peculiar labels. This heterogeneity in labeling biosimilars itself points to the complexity of understanding by different regulatory agencies about the exact nature of these products. It is anticipated that over time, “biosimilars” would become the default definition for the products that are introduced once the patents expire on the gene sequences that are associated with specific molecules.

Sandoz refused to comply with the suggested patent dance, wherein the biosimilar company provides a complete submission dossier to the originator within 60 days of the acceptance of the 351(k) application; Sandoz asserted that it was not required, but Amgen suggested otherwise. The FDA refused to get involved, and Amgen could not get a court injunction against Sandoz. The second aspect of a 180-day notice was also challenged by Sandoz, saying that the term starts with the acceptance of the application; Amgen asserted it starts after approval of the product.

Parts of this chapter will apply to the regulatory process, and instead of splitting this into two chapters, I have provided a comprehensive review upfront. A stereotype view of this subject would be that this is an issue best handled by a legal team, so why bring it in at this time? The fact is that long before development begins, legal challenges to developing the product must be addressed, and this goes way beyond what you would see in small molecules, where composition patents are the first ones to consider, followed by any barriers to maintaining the Q/Q status of the product.

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