Biogeneric


Also found in: Dictionary.
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 ?
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.
Biopharma Manufacturing Markets: Biomanufacturing contract services and supplies markets continue to expand
The patented Biogeneric software technology offers sophisticated restoration design and superb functionality.
CAD/CAM dentistry for today's on-the-go military
Hospira also has three biotech cancer medicines it has yet to disclose in its pipeline as it prepares for expansion of the biogeneric field.
Hospira Inc
To enumerate the regulatory hurdles faced by Indian companies in exporting biogenerics to regulated markets.
A study on the state of the biopharmaceutical sector in India with emphasis on its exports
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.
Public sector health care purchasers convene in Washington, D.C.: state and local governments and pension plans provide health benefits to 16 million working and retired American and their families. It is imperative that they begin identifying what is needed for effective health care reform
* Biosimiliars will become more prevalent in Europe and pressure to approve biogeneric pharmaceuticals will increase in the US ...
BURRILL'S BIOTECH OUTLOOK FOR 2007 AND LOOK BACK AT 2006
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.
Special delivery: health insurers need to manage the cost and use of specialty drugs
The United States Food and Drug Administration has approved the tablets, which are a biogeneric version of Lipitor tablets.
Generic Anti-Cholesterol Drug Introduced by Dr Reddya[euro](tm)s in US
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.
Sales of biologics to plummet 60% by 2015 as biogeneric competition becomes a reality
Handbook of biogeneric therapeutic proteins; regulatory, manufacturing, testing, and patent issues.
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.
Huge potential savings from biogenerics: a report by economist Dr Robert J. Shapiro, former Under Secretary of Commerce in the Clinton Administration, and commissioned by Insmed (Nasdaq: INSM), identifies potential cost savings of approximately $378 billion over the next 20 years from making follow on biologics (FOBs) available in the US
Keywords: biogeneric, biosimilar, generic, biopharmaceutical
Biogenerics 2007: how far have we come?
Medical browser ?
Full browser ?