What Factors May Impact the Likelihood of First Abbreviated New Drug Application (ANDA) Submission for a Reference Product?

Wittayanukorn, Saranrat; Rosenberg, Matthew; Schick, Andreas; Hu, Mengqi; Wang, Z; Babiskin, Andrew; Zhao, Liang

doi:10.1016/j.jval.2018.04.785

Cited by 3 publications

(2 citation statements)

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“…There are currently three key tool sets that have been aiding the modernization of the generic regulatory program in the agency. These tool sets are as follows: (i) physiologically based PK (PBPK) models for oral and nonoral drugs that can guide the characterization of drug release, absorption, and regional drug distribution; (ii) quantitative clinical pharmacology (QCP) tool sets consisting of population PK, PK-PD, and exposure-response models 10 ; and (iii) big data tool sets, such as machine learning techniques, as the next generation of pharmacometrics tool sets, 11 analytics for complex mixtures, 12 systems pharmacology, 13 risk-based models, 14 business process models, [15][16] and postmarketing data analytics. These tool sets are used to assist generic drug development and review policy development, such as general guidance and PSG, and regulatory decision making.…”

Section: Benefits Scope and Tools Of Qmm In Generic Drug Development ...mentioning

confidence: 99%

Generating Model Integrated Evidence for Generic Drug Development and Assessment

Zhao

Kim

Zhang

et al. 2019

Clin Pharma and Therapeutics

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Quantitative methods and modeling (QMM) covers a broad spectrum of tool sets, of which physiologically based models and quantitative clinical pharmacology are most critical for generic drugs. QMM has been increasingly applied by the US Food and Drug Administration (FDA) to facilitating generic drug development and review, and has played a critical role in the modernization of bioequivalence (BE) assessment, especially for locally acting drug products, complex products of other types, and modified-release solid oral dosage forms. QMM has aided the development of novel BE methods, in vitro-only BE approaches, and risk-based evaluations. The future of QMM is model integrated evidence or virtual BE studies that can potentially provide pivotal information for generic drug approval. In summary, QMM is indispensable in modernizing generic drug development, BE assessment, and regulatory decision makings. Regulatory examples demonstrate how QMM can be used in modernizing generic drug development, addressing challenges in BE assessment, and supporting regulatory decision making.New drug development and approval depends on sufficient in vitro and in vivo evidence to support the regulatory assessment of drug product efficacy and safety. A generic drug is approved on the basis of sufficient demonstration of sameness to the corresponding brand drug. For both new and generic drugs, quantitative methods and modeling (QMM) can accelerate product development and regulatory assessment.For both new and generic drug development and approval, a mathematical model can be thought of as a knowledge management system that integrates all scientific understanding and existing data about a drug product regarding its formulation, in vitro/in vivo release, pharmacokinetics (PK), pharmacodynamics (PD), and clinical responses. The discipline of QMM both builds these models and uses them to aid both regulatory and business decisions. QMM in new drug developmentFor new drug development, as shown in Figure 1, the data axis includes information and datasets collected through the full Research and Development course for the active pharmaceutical ingredient (API), formulation, in vitro release, the targeted in vivo release profile, animal and human drug PK, PD response(s), and clinical responses in terms of both efficacy and safety end points. Models describing the relationships between the datasets are captured in the model axis. The use of these models can accelerate decisions and optimize the collection of data.Model-informed drug development (MIDD) under the Prescription Drug User Fee Amendments of 2017 (PDUFA VI) is an initiative to use these models to decrease development uncertainty, cost, time, attritions, and failure rates. It aims to inform drug development and regulatory decision makings by using population PK, dose/exposure-response relationships, and biological and statistical models derived from preclinical and clinical data sources. An MIDD pilot program was launched with goals to provide an opportunity for drug developers and the FDA t...

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Section: Benefits Scope and Tools Of Qmm In Generic Drug Development ...mentioning

confidence: 99%

Generating Model Integrated Evidence for Generic Drug Development and Assessment

Zhao

Kim

Zhang

et al. 2019

Clin Pharma and Therapeutics

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“…)[7].Sambathkumar R, et al "Competitive Landscape and Brand Equivalents: Implications for ANDA (Abbreviated New Drug Application) Approval". Pharmaceut Drug Regul Affair J 2024, 7(1): 000157.…”

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Competitive Landscape and Brand Equivalents: Implications for ANDA (Abbreviated New Drug Application) Approval

2024

PDRAJ

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Generic drugs stand as a beacon of hope within the realm of medicine, offering a pragmatic and wallet-friendly solution for patients seeking essential treatments. They open the doors to the same therapeutic benefits as their brand-name counterparts, all without imposing exorbitant financial burdens. This revolutionary journey begins with the Abbreviated New Drug Application (ANDA), a pivotal gateway into the stringent regulatory landscape overseen by the U.S. Food and Drug Administration (FDA). Unlike the labyrinthine process faced by novel drugs, generics enjoy a streamlined path to approval, showcasing their equivalence to the original through meticulous validation of identical active ingredients and efficacy. This efficient route not only saves precious time but also preserves valuable financial resources, sidestepping the need for redundant testing mandated for new drugs. With the coveted FDA seal of approval, these generic marvels burst onto the market, offering patients a cost-effective alternative without any compromise on quality or effectiveness. In essence, generic drugs emerge as beacons of accessibility, ensuring that essential treatments reach the masses while steadfastly upholding the highest standards of safety and efficacy. They represent not just a practical solution, but a transformative force in democratizing healthcare access for all.

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Abbreviated New Drug Application Process: A Gift for The Industry and The Patients

Ahad¹,

Chinthaginjala²,

Reddy³

et al. 2021

AJRC

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The United States Food and Drug Administration (USFDA) is one of the main regulated agencies wherein the submission and approval of the new drugs is done. This review is based on the process of submission to the ANDA as per FDA norms as described in paragraph IV submission in Federal Food, Drug, and Cosmetic Act (FD and C Act). No drug would exist in the market until it gets accepted by regulatory authorities. The ANDA submission is for those firms seeking to copy branded drugs before running out of patents to get profit on them. A generic applicant must provide in its application a "certification" that a patent submitted to FDA by the brand-name drug's sponsor and scheduled in FDA's Approved Drug Products with Therapeutic Equivalence Evaluations (the Orange Book). A Generic Product must meet the standards recognized by FDA in Reference listed drugs (RLD). This study concludes the process of ANDA submission to FDA and acts correlated to the submission in paragraph IV, the details of ANDA filling in the eCTD format and overview of the review process the checklist to the applicant.

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What Factors May Impact the Likelihood of First Abbreviated New Drug Application (ANDA) Submission for a Reference Product?

Cited by 3 publications

References 0 publications

Generating Model Integrated Evidence for Generic Drug Development and Assessment

Generating Model Integrated Evidence for Generic Drug Development and Assessment

Competitive Landscape and Brand Equivalents: Implications for ANDA (Abbreviated New Drug Application) Approval

Abbreviated New Drug Application Process: A Gift for The Industry and The Patients

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