biosimilar

(redirected from Biogenerics)
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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 ?
GPhA president and chief executive officer Kathleen Jaeger contends that biogenerics could save as much as $67 billion over the course of a decade.
To enumerate the regulatory hurdles faced by Indian companies in exporting biogenerics to regulated markets.
"The mere fact that the FTC is conducting this roundtable demonstrates the growing momentum behind ensuring that consumers have access to safe and affordable biogenerics sooner rather than later.
Biogenerics. One priority for the Roundtable over the past several months has been to raise awareness on Capitol Hill concerning the high cost of biopharmaceuticals and the need to establish a safe means for the approval of biogenerics.
There is currently no pathway for regulating generic versions of complex, expensive biologic drugs, also referred to as biogenerics, follow-on biologics, and biosimilars.
The biotech drug industry has benefited in general from high prices, but the recent refusal of a number of health insurance organizations to pay for new biotech drugs and the development of biogenerics are likely to bring about a change in pricing strategy.
This act would bring in competition and institute a framework regulating the production of biogenerics to ensure they are equivalent to the original.
"Every step of the way, roadblocks were put" to ensure that generics were not used, says William Haddad, chair and chief executive officer of the New York-based generic biotechnology firm Biogenerics Inc.
Defining a regulatory framework for approving biogenerics is an important evolving regulatory concern in industrialized countries.
In 1999, he founded Biogenerics, Inc., which produced generics, and a year later he went to work for Cipla as a volunteer to reduce the price of AIDS medications in Africa.
One company, BioGenerics of Greenock, developed the test after approaches from worried parents.