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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
References in periodicals archive ?
33: ROW Prescription Volume for Generic and Biogeneric Drugs by Segment in Millions, 2008 - 2013
TPI plans to file drug applications in the United States after the FDA identifies its requirements for approving biogeneric drugs.
Creating a real pathway for biogenerics to increase competition for high cost biotech products along with providing greater incentives for mail-service pharmacies in public programs are common sense proposals which both lower costs and increase access.
This challenge is now showing signs of easing, particularly in Western Europe where the European Agency for the Evaluation of Medicinal Products (EMEA) is now accepting Market Authorisation Applications (MAA's) for biogeneric products, which show proven biosimilarity in place of clinical trials.
Today's report from the FTC is yet another endorsement of the need to move forward on passage of legislation that brings affordable biogenerics to patients sooner rather than later.
The widely accepted perception that branded products are much more efficacious than generic and biogeneric products is one factor that is likely to restrain overall market growth.
We believe bipartisan legislation authored by Chairman Waxman to establish an approval pathway for biogenerics finds the appropriate balance between innovation and competition in the biotech market.
2) Hospira's biogeneric, Retacrit(R) (epoetin zeta), is a treatment for anemia associated with chronic kidney failure and chemotherapy-induced anemia, and is available in 15 European countries today.
The time has also come for Congress to give FDA the authority and flexibility to create a workable biogenerics approval pathway.
Estimates for savings from biogeneric drugs range from $12 billion over 10 years by the Congressional Budget Office (CBO)(1), which assumed a 12-year exclusivity period and focused on savings to the U.
1427, the Bipartisan Biogenerics Consensus Bill: "Promoting Innovation and Access to Life-Saving Medicine Act.