Scientific and regulatory activities initiated by the U.S. Food and drug administration to foster approvals of generic dry powder inhalers: Bioequivalence perspective

Bryan Newman; Andrew Babiskin; Elizabeth Bielski; Susan Boc; Sneha Dhapare; Lanyan Fang; Katharine Feibus; Anubhav Kaviratna; Bing V Li; Markham C Luke; Tian Ma; Michael Spagnola; Ross L Walenga; Zhong Wang; Liang Zhao; Nashwa El-Gendy; Craig M Bertha; Mohammed Abd El-Shafy; Dhaval K Gaglani

doi:10.1016/j.addr.2022.114526

Scientific and regulatory activities initiated by the U.S. Food and drug administration to foster approvals of generic dry powder inhalers: Bioequivalence perspective

Adv Drug Deliv Rev. 2022 Nov:190:114526. doi: 10.1016/j.addr.2022.114526. Epub 2022 Sep 5.

Authors

Bryan Newman¹, Andrew Babiskin², Elizabeth Bielski¹, Susan Boc¹, Sneha Dhapare¹, Lanyan Fang², Katharine Feibus¹, Anubhav Kaviratna¹, Bing V Li³, Markham C Luke¹, Tian Ma⁴, Michael Spagnola⁵, Ross L Walenga⁶, Zhong Wang², Liang Zhao², Nashwa El-Gendy⁷, Craig M Bertha⁸, Mohammed Abd El-Shafy⁷, Dhaval K Gaglani⁷

Affiliations

¹ Division of Therapeutic Performance I, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
² Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
³ Office of Bioequivalence, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
⁴ Division of Bioequivalence I, Office of Bioequivalence, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
⁵ Division of Clinical Safety and Surveillance, Office of Safety and Clinical Evaluation, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
⁶ Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA. Electronic address: Ross.Walenga@fda.hhs.gov.
⁷ Division of Immediate and Modified Release Drug Products III, Office of Lifecycle Drug Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
⁸ Division of New Drug Products II, Office of New Drug Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.

PMID: 36067967
DOI: 10.1016/j.addr.2022.114526

Abstract

Regulatory science for generic dry powder inhalers (DPIs) in the United States (U.S.) has evolved over the last decade. In 2013, the U.S. Food and Drug Administration (FDA) published the draft product-specific guidance (PSG) for fluticasone propionate and salmeterol xinafoate inhalation powder. This was the first PSG for a DPI available in the U.S., which provided details on a weight-of-evidence approach for establishing bioequivalence (BE). A variety of research activities including in vivo and in vitro studies were used to support these recommendations, which have led to the first approval of a generic DPI in the U.S. for fluticasone propionate and salmeterol xinafoate inhalation powder in January of 2019. This review describes the scientific and regulatory activities that have been initiated by FDA to support the current BE recommendations for DPIs that led to the first generic DPI approvals, as well as research with novel in vitro and in silico methods that may potentially facilitate generic DPI development and approval.

Keywords: Bioequivalence; Dry powder inhaler; Generic drug product.

Published by Elsevier B.V.

Publication types

Review

MeSH terms

Administration, Inhalation
Drugs, Generic*
Dry Powder Inhalers*
Fluticasone
Humans
Powders
Salmeterol Xinafoate
Therapeutic Equivalency
United States
United States Food and Drug Administration

Substances

Drugs, Generic
Powders
Salmeterol Xinafoate
Fluticasone