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 ?
companies involved in the lower value international and lesser regulated biogenerics markets.
Concerning the future benefits of biogenerics, Neas added: "If we do not address successfully the biogenerics issues, biologics will bankrupt the health care system and the economy.
Hospira also has three biotech cancer medicines it has yet to disclose in its pipeline as it prepares for expansion of the biogeneric field.
There is no doubt that a sound balance must be struck between innovation and competition in any truly workable biogenerics legislation.
A handful of these biogenerics are available in the United States--mainly early versions of biosynthetic insulin and human growth hormone produced with recombinant DNA technologies--after being grandfathered in Hatch-Waxman under the US Food, Drug and Cosmetics Act.
While there are not yet any so-called biogenerics available to patients in the United States,.
Hospira is the world leader in generic injectable pharmaceuticals and has the capabilities and experience to successfully sell biogenerics in these important markets," said Jung-Sin Seo, chief executive officer and chairman, Celltrion.
and overseas patents lapse in coming years as INS-19, INS-20 and similar biogenerics from other drugmakers make inroads.
Waltham, MA), one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that the United States and European markets for branded biologics in the four key biologic classes (ESPs, G-CSF, insulin and insulin analogues, and hGH) will decline through 2015 as biogenerics gradually become available.
However, biogenerics are expected to sell for only 35% less than brand name drugs.
With the advancements in the biogenerics and gene therapy markets, the therapeutic proteins market is expected to show a moderate growth rate in the coming years.