For information on traditional small-molecule generic drugs, see Generic Drugs (Small Molecule).
Information on what are generic drugs can also be got at InternationalDrugMart
In the U.S., there is no formal procedure for the testing and approval of generic biologics. Due to the exponentially more complicated nature of biologic drugs as compared to traditional small-molecule medicines, even the smallest variation in the manufacturing process can produce toxic results, as seen in the Amgen/Johnson & Johnson Procrit ordeal. Biotech companies are quick to point this out, citing the complexity of biologics as a reason why generic versions are unfeasible. Nonetheless, there is mounting political pressure to develop a path to approval for biogenerics and biosimilars, as evidenced by a recent bill passed by a Senate committee.
European regulatory agencies have been quicker to respond to the question of generic biologics, issuing a set of guidelines for the approval of biosimilars. This could pressure the U.S. FDA to follow suit and establish its own approval process for generic biologics, but this is yet to be seen. The process outlined by the European Medicines Agency (EMEA) is hardly a breeze, however. Whereas traditional small-molecule generics can be brought to market quickly and at minimal cost, generic biologics require a minimum of two clinical trials and extensive testing for toxic side effects. This makes the approval process for biosimilars nearly as rigorous and expensive as the approval process for new biologics, which could discourage some companies from entering the generic biopharmaceutical market. These more strict regulatory guidelines would likely cut down on the cutthroat pricing and intense competition found in the traditional generic drug market. Also, by imposing stringent rules for approval, the biosimilar market is likely to be limited to large, mature companies who have the resources to see the process through.
Among the leading figures in the biopharmaceutical industry are: