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 ?
2 Growth Trends for Japan Generics and Biogenerics Drug Market, 2008 - 2013
Regulatory issues have been the biggest challenge to the development of the biogenerics market in North America and Western Europe.
Countless Americans are waiting for more affordable biogenerics to treat their serious medical conditions and it is clear that 12 to 14 years of exclusivity will do nothing to get them the help they desperately need.
Biogenerics are imitator products of medicine produced on a biological basis (cell cultures).
The information and analysis presented in this report are based on an extensive survey of senior management in the biogeneric drug industry.
The FTC's expertise and their findings in support of a legislative pathway allowing the Food and Drug Administration to approve biogenerics in light of market-based competition that drives innovation should be heeded by Congress as we consider health care reform," Golding said.
However, even while the generics and biogenerics market demonstrates great potential, unclear regulatory processes and patent issues are likely to pose a major challenge.
Nathan Deal (R-GA), known as the "Promoting Innovation and Access to Life-Saving Medicines Act," that establishes a clear pathway for the FDA to bring safe, affordable biogeneric medications to market in a timely manner.
As momentum grows on Capitol Hill for passage of biogenerics legislation, both generic and brand companies have clearly stated that they are ready to produce these lifesaving medicines and many are doing so in Europe and around the world.
We enthusiastically support legislation in Congress to make high-quality, safe and more affordable biogenerics available in this country.
The time has also come for Congress to give FDA the authority and flexibility to create a workable biogenerics approval pathway.
Despite this setback, the biogenerics debate marches on and is a bellwether for Washington's capacity for real health reform.