me too drug
Definition A popular term for a generic drug with an identical formulation and stated indications as a drug previously approved by the FDA.
Comment Me too drugs are usually approved automatically, based on their virtual identity with other formulations. Such drugs have already passed the clinical testing phase, the appropriate regulatory hurdles, and product safety standards Only a minority offer a clear clinical advantages over existing therapies…the preponderance of ‘me too’ drugs has created a highly competitive marketplace…Pharmaceutical companies wage aggressive campaigns to change prescribers’ habits and to distinguish their products from competing ones, even when the products are virtually indistinguishable. This occurs in many therapeutic classes–e.g., antiulcer products, ACE inhibitors, calcium channel blockers, selective serotonin-reuptake-inhibitor antidepressants, NSAIDs, and others; victory in these ‘wars’ can mean millions of dollars for a drug company; for patients and providers it can mean misleading promotions, conflicts of interest, increased costs of health care and …inappropriate prescribing NEJM 1994; 331:1350sa; the FDA approves ± 35 new molecular entities/year; drug company techniques to induce physicians to change their prescribing habits from one me too agent to another include seeding trials, unsubstantiated claims of superiority over competing products, and switch campaigns.
Synonym Duplicative drug