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 ?
Generic medicines and biogenerics will be crucial to curbing the growth of rapidly expanding health costs moving forward.
Hospira also has three biotech cancer medicines it has yet to disclose in its pipeline as it prepares for expansion of the biogeneric field.
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.
While there are not yet any so-called biogenerics available to patients in the United States,.
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.
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.
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.
Also, biogeneric companies will have to conduct costly clinical trials to prove safety and effectiveness.
The approaching age of biogeneric and biosimilar medicines in the United States presents magnificent growth opportunities for the generic pharmaceutical industry.