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A biopharmaceutical or other biological product—e.g., insulin, hGH—that has emerged from patent protection and can be manufactured by a party other than the original developer using either identical or different manufacturing processes; for FDA approval, the product must be bioequivalent or comparable to the original innovative product
Segen's Medical Dictionary. © 2012 Farlex, Inc. All rights reserved.
References in periodicals archive ?
Much new manufacturing capacity is being added internationally, with biopharmaceutical markets in many developing countries growing and more domestic companies increasingly serving these markets, generally with biogeneric copies of innovator products.
The patented Biogeneric software technology offers sophisticated restoration design and superb functionality.
Hospira also has three biotech cancer medicines it has yet to disclose in its pipeline as it prepares for expansion of the biogeneric field.
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.
* Biosimiliars will become more prevalent in Europe and pressure to approve biogeneric pharmaceuticals will increase in the US ...
Unlike traditional drugs, biologics do not currently have a Food and Drug Administration review and approval process for biogeneric drugs once the innovator drug's patent has expired.
The United States Food and Drug Administration has approved the tablets, which are a biogeneric version of Lipitor tablets.
According to the report entitled Biogenerics 2006-2015: An Emerging Reality for Biologic Brands, companies with biologic products facing patent expiries will face significant competition from a collection of biogeneric companies which are already developing follow-on agents.
Handbook of biogeneric therapeutic proteins; regulatory, manufacturing, testing, and patent issues.
These issues will be especially important and challenging if, as expected, the new regulations adopt a standard of effective "similarity" to the original biologic instead of precise "bioequivalence" as part of an approval process which, like the one for traditional generic pharmaceuticals, does not require that "biogeneric" producers conduct their own, extensive clinical trials.
Keywords: biogeneric, biosimilar, generic, biopharmaceutical