biosimilar

(redirected from Follow-on Biologic)
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biosimilar

(bī′ō-sĭm′ə-lər)
adj.
Highly similar in function and effect to an existing biological product, especially to a biologic that has already been clinically tested and approved for use.
n.
A biological product that is biosimilar to an existing product, especially to a biologic.

biosimilar

adjective Referring to a biosimilar therapeutics agent.
 
noun A biopharmaceutical which is produced by a different manufacturer after the expiration of the patent and marketing exclusivity of an original innovative biological product (e.g., a therapeutic monoclonal antibody).
 
In contrast to small (non-biological) agents, for which manufacturing an equivalent product is a relatively straightforward chemical process, biosimilars are not produced from the original clones and cell lines used to produce the tested and proven-effective agent; they thus may have therapeutic and metabolic profiles that differ from the clinically tested and proven products.

biosimilar

(bi?o-sim'i-lar) [ bio- + similar]
1. A generic version of a biologically active pharmaceutical agent, e.g., of a manufactured antibody or hormone.
2. Pert. to such a generic version.
Synonym: follow-on biologicbiosimilarity
References in periodicals archive ?
With combined sales totaling $30 billion in 2010, coupled with a recently introduced abbreviated approval pathway for follow-on biologics and an impending patent cliff for blockbuster drugs, the biologics arena looks set to offer a very enticing prospect to pharmaceutical companies and generics alike.
Because Big Pharma has unique advantages compared with generic companies regarding the ability to successfully compete in the follow-on biologics arena, namely existing manufacturing capabilities, funding, experience with clinical trials and physician detailing, it makes sense that Big Pharma companies would consider the opportunity.
Follow-on biologics, also referred to as "biosimilar" or "generic biologics," refer to the generic reproduction of biologics, complex medicines developed from living organisms.
Follow-on biologics have been widely predicted to be the fastest-growing segment of the U.
The FDA has held and participated in several workshops to discuss the issues and regulatory scheme for follow-on biologics and promised to release guidance for the industry on the regulatory issues and requirements for approval of these products.
In order for the biotechnology industry to continue to produce new life-enhancing and life-saving therapies for patients around the world, there must be the potential for a return on the significant investment required to bring a therapy to market, and a carefully constructed incentive structure must be part of any statutory pathway for follow-on biologics," stated Greenwood.
Any legislative discussion of creating a pathway for follow-on biologics must first seek to protect patient safety and preserve the intellectual property rights and incentives that drive biomedical innovation.
Follow-on biologics involve difficult questions surrounding science, patient safety and intellectual property.