title: Scientific and Regulatory Considerations for Generic Complex Drug Products Containing Nanomaterials.
abstract: In the past few decades, the development of medicine at the nanoscale has been applied to oral and parenteral dosage forms in a wide range of therapeutic areas to enhance drug delivery and reduce toxicity. An obvious response to these benefits is reflected in higher market shares of complex drug products containing nanomaterials than that of conventional formulations containing the same active ingredient. The surging market interest has encouraged the pharmaceutical industry to develop cost-effective generic versions of complex drug products based on nanotechnology when the associated patent and exclusivity on the reference products have expired. Due to their complex nature, nanotechnology-based drugs present unique challenges in determining equivalence standards between generic and innovator products. This manuscript attempts to provide the scientific rationales and regulatory considerations of key equivalence standards (e.g., in vivo studies and in vitro physicochemical characterization) for oral drugs containing nanomaterials, iron-carbohydrate complexes, liposomes, protein-bound drugs, nanotube-forming drugs, and nano emulsions. It also presents active research studies in bridging regulatory and scientific gaps for establishing equivalence of complex products containing nanomaterials. We hope that open communication among industry, academia, and regulatory agencies will accelerate the development and approval processes of generic complex products based on nanotechnology.
authors.affiliation: Center for Drug Evaluation and Research, Office of Generic Drugs, Office of Research and Standards, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993, USA.
authors.forename: Nan
authors.initials: N
authors.lastname: Zheng
authors.affiliation: Center for Drug Evaluation and Research, Office of Generic Drugs, Office of Research and Standards, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993, USA.
authors.forename: Dajun D
authors.initials: DD
authors.lastname: Sun
authors.affiliation: Center for Drug Evaluation and Research, Office of Generic Drugs, Office of Research and Standards, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993, USA.
authors.forename: Peng
authors.initials: P
authors.lastname: Zou
authors.affiliation: Center for Drug Evaluation and Research, Office of Generic Drugs, Office of Research and Standards, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993, USA. Wenlei.Jiang@fda.hhs.gov.
authors.forename: Wenlei
authors.initials: W
authors.lastname: Jiang
mesh_terms: D000284:Administration, Oral; D004335:Drug and Narcotic Control; D016568:Drugs, Generic; D007263:Infusions, Parenteral; D049329:Nanostructures; D036103:Nanotechnology
chemical_list: D016568:Drugs, Generic
keywords: equivalence; generic; nanomaterial; nanotechnology