A new paradigm for topical generic drug products: Impact on therapeutic access

Medication Cost-Savings and Utilization of Generic Inhaled Corticosteroid (ICS) and Long-Acting Beta-Agonist (LABA) Drug Products in the USA

“…On average, the marketing of a first generic without a competing authorized generic provided a cost-savings to the patient at 31% for Advair Diskus, or AG for Symbicort. C Copayment structure for the payments for selected orally inhaled drug products (OIDPs) [23,27,[33][34][35]. Therefore, the introduction of Wixela™ Inhub™ inhalation powder has performed well compared to other generic products with competing authorized generics, as well as to those without.…”

Physiologically‐based pharmacokinetic modeling to support bioequivalence and approval of generic products: A case for diclofenac sodium topical gel, 1%

“…4 For locally acting drug products applied on the skin as semisolid dosage forms, BE approaches include drug product characterization studies on the product microstructure, vasoconstrictor studies, BE studies with pharmacokinetic (PK) end points, and comparative clinical end point BE studies. 1,5,6 Comparative clinical end point BE studies specifically can be costly, time-consuming, and less sensitive at detecting formulation differences between a test and a reference product due to the absence of established dose-response relationship and modest efficacy for the active pharmaceutical ingredient (API) that exerts its pharmacological activity following skin application. 1,6,7 Physiologically-based pharmacokinetic (PBPK) modeling and simulation is a methodology that describes the PKs of the active ingredient in the body in a quantitative and mechanistic manner.…”

“…The Agency makes recommendations for BE studies based on the current scientific understanding of a particular drug product captured in product‐specific guidances (PSGs) that are publicly available and updated at regular intervals 4 . For locally acting drug products applied on the skin as semisolid dosage forms, BE approaches include drug product characterization studies on the product microstructure, vasoconstrictor studies, BE studies with pharmacokinetic (PK) end points, and comparative clinical end point BE studies 1,5,6 . Comparative clinical end point BE studies specifically can be costly, time‐consuming, and less sensitive at detecting formulation differences between a test and a reference product due to the absence of established dose‐response relationship and modest efficacy for the active pharmaceutical ingredient (API) that exerts its pharmacological activity following skin application 1,6,7 …”

Physiologically‐Based Pharmacokinetic Modeling to Support Determination of Bioequivalence for Dermatological Drug Products: Scientific and Regulatory Considerations

“…24,25 Comparative clinical end point BE studies are often less sensitive at detecting formulation differences between the test and the reference product, costly (as they require a large study size to establish BE), and time-consuming (as clinical efficacy is often observed days/weeks following the product application). 24,25 As such, these studies may pose a challenge for generic drug product developers. 24 The FDA has recognized the role of PBPK modeling and simulation in supporting the development program of generics, alternative BE approaches, and drug product approval.…”

“…The FDA issues product‐specific guidances 23 containing recommendations for bioequivalence (BE) studies for locally acting drug products applied on the skin as semisolid dosage forms or transdermal delivery systems (TDS). These BE approaches include physical and chemical characterization of drug product, vasoconstrictor studies, BE studies with pharmacokinetic (PK) end points, and/or comparative clinical end point BE studies 24,25 . Comparative clinical end point BE studies are often less sensitive at detecting formulation differences between the test and the reference product, costly (as they require a large study size to establish BE), and time‐consuming (as clinical efficacy is often observed days/weeks following the product application) 24,25 .…”