Abstract
Complex generics are generic versions of drug products that generally have complex active ingredients, complex formulations, complex routes of delivery, complex dosage forms, are complex drug-device combination products, or have other characteristics that can make it complex to demonstrate bioequivalence or to develop as generics. These complex products (i.e. complex generics) are an important element of the United States (U.S.) Food and Drug Administration’s (FDA’s) Generic Drug User Fee Amendments (GDUFA) II Commitment Letter. The Center for Research on Complex Generics (CRCG) was formed by a grant from the FDA to address challenges associated with the development of complex generics. To understand these challenges, the CRCG conducted a “Survey of Scientific Challenges in the Development of Complex Generics”. The three main areas of questioning were directed toward which (types of) complex products, which methods of analysis to support a demonstration of bioequivalence, and which educational topics the CRCG should prioritize. The survey was open to the public on a website maintained by the CRCG. Regarding complex products, the top three selections were complex injectables, formulations, and nanomaterials; drug-device combination products; and inhalation and nasal products. Regarding methods of analysis, the top three selections were locally-acting physiologically-based pharmacokinetic modeling; oral absorption models and bioequivalence; and data analytics and machine learning. Regarding educational topics, the top three selections were complex injectables, formulations, and nanomaterials; drug-device combination products; and data analytics, including quantitative methods and modeling & simulation. These survey results will help prioritize the CRCG’s initial research and educational initiatives.
Highlights
The scientific and regulatory framework for developing generic versions of brand name drugs was established by the Drug Price Competition and Patent Term Restoration Act of 1984
These “Hatch–Waxman Amendments” established the approval pathway under which generic drug developers can submit an abbreviated new drug application (ANDA) to the United States (U.S.) Food and Drug Administration (FDA) that would include certain types of information and evidence to support the approval of an ANDA
Per the Generic Drug User Fee Amendments (GDUFA) II Commitment Letter of 5/12/2016, complex products generally include: 1. Products with complex active ingredients; complex formulations; complex routes of delivery or complex dosage forms; 2
Summary
The scientific and regulatory framework for developing generic versions of brand name drugs was established by the Drug Price Competition and Patent Term Restoration Act of 1984. Priority initiatives for fiscal year 2021 include complex active ingredients, formulations, or dosage forms; complex routes of delivery; complex drug-device combination products; and tools and methodologies for PE, BE and therapeutic equivalence (TE) evaluation [3]. These priority initiatives reflect categories of complex generic products described in the GDUFA II Commitment Letter [2]. A Wald Chi-square test was used to assess differences due to the demographic background of respondents in replies about types of complex products, methods of analysis, and educational topics (e.g., Did generic drug executive or management versus all others differ in selecting drug-device combination products as a complex product?). Formulations, and nanomaterials Drug-device combination products Inhalation and nasal products Long-acting injectables and implants Complex mixtures and peptides Topical dermatologic drug products Ophthalmic products Other drug or drug product
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