Biogeneric


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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 ?
Generic medicines and biogenerics will be crucial to curbing the growth of rapidly expanding health costs moving forward.
'Controlling costs is essential to sustainability of health care'
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
The mere fact that the FTC is conducting this roundtable demonstrates the growing momentum behind ensuring that consumers have access to safe and affordable biogenerics sooner rather than later.
GPhA Looks to Biogenerics
As noted earlier, issues of biogeneric safety and effectiveness arise from the complexity and variability of their composition and manufacture.
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
However, the Food and Drug Administration (FDA) currently lacks the authority to approve 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
While there are not yet any so-called biogenerics available to patients in the United States,.
Push to cut health care costs good for generics
This partnership gives Hospira access to Celltrion's large biogenerics portfolio, and is an excellent example of Hospira's commitment to organic and inorganic growth.
Newsmakers: Dr. Michael Gilman: Q&A with a new biotech about building a virtual network
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
Hospira will now have full global rights to the biogeneric filgrastim that had previously been part of a strategic collaboration between Hospira and PLIVA/Barr, now owned by Teva Pharmaceutical Industries Ltd.
Roche restructures executives: Hospira acquires biogeneric
Also, biogeneric companies will have to conduct costly clinical trials to prove safety and effectiveness.
Biotech
The approaching age of biogeneric and biosimilar medicines in the United States presents magnificent growth opportunities for the generic pharmaceutical industry.
The Generic Pharmaceutical Association (GPhA)
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