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17. Evans C, Cipolla D, Chesworth T, Agurell E, Ahrens R, Conner D, Dissanayake S, Dolovich M, Doub W, Fuglsang A, García Arieta A, Golden M, Hermann R, Hochhaus G, Holmes S, Lafferty P, Lya- pustina S, Nair P, O'Connor D, Parkins D, Peterson I, Reisner C, Sandell D, Singh GJP, Weda M and Wat- son P. Equivalence Considerations for Orally Inhaled Products for Local Action—ISAM/IPAC-RS Euro- pean Workshop Report. Journal of Aerosol Medicine and Pulmonary Drug Delivery. 25(3): 117-139 (June 2012). 18. Burmeister Getz E, Carroll KJ, Jones B and Benet LZ. Batch-to-batch Pharmacokinetic Variability Con- founds Current Bioequivalence Regulations: A Dry Powder Inhaler Randomized Clinical Trial. Clinical Pharmacology & erapeutics. 100: 223-231 (2016). 19. Burmeister Getz E, Carroll KJ, Mielke J, Benet LZ and Jones B. Between-batch Pharmacokinetic Variabil- ity Inflates Type I Error Rate in Conventional Bioequiv- alence Trials: A Randomized Advair Diskus Clinical Trial. Clinical Pharmacology & erapeutics. 101:331- 340 (2017). 20. Burmeister Getz E, Carroll KJ, Mielke J, Jones B and Benet LZ. Pharmacokinetic Behavior of Flutica- sone Propionate and Salmeterol from Advair Diskus: The Consequences of Batch Variability. Respiratory Drug Delivery Europe 2017. 1:25-34 (2017). 21. Darrow JJ, Avorn J, Kesselheim AS. FDA Approval and Regulation of Pharmaceuticals, 1983-2018. Jour- nal of the American Medical Association. 323(2):164- 176 (2020). This Point of View article was peer-reviewed prior to publication. Igor Gonda, PhD, is Founder and CEO of Respidex, LLC, PO Box 218, Dennis, MA, 02638, US, Tel.: +1 510 731- 8820, e article reflects some of his personal views. (Corresponding author) Philippe Rogueda, PhD, is Chief Business Officer, Merxin, Ltd., 1 Innovation Drive, King's Lynn, PE30 5BY, UK, Tel.:+44 1553 403070,, www. e article reflects some of his personal opin- ions, not necessarily those of Merxin, Ltd. David Cipolla, PhD, is Vice President, Research, Insmed, Inc., 700 US Highway 202/206, Bridgewa- ter, NJ, 08807-1704, US, Tel.: (w) +1 732 487-7252 (m) +1 925 336-0823, e article reflects some of his opinions, not necessarily those of Insmed, Inc. or its affiliations. 5. Khullar D, Ohn JA, Trusheim MS and Bach PR. Understanding the Rewards of Successful Drug Devel- opment—Thinking Inside the Box. New England Journal of Medicine 382:473-480 (2020). 6. Mylan. Wixela® Inhub®. 7. Mylan Announces FDA Approval of Wixela® Inhub® (fluticasone propionate and salmeterol inhalation pow- der, USP), First Generic of Advair Diskus® (fluticasone propionate and salmeterol inhalation powder) http:// 8. Ng D, Kerwin EM, White MV, Miller SD, Haughie S, Ward JK and Allan R. Clinical Bioequivalence of Wixela ® Inhub ® and Advair Diskus in Adults With Asthma. Journal of Aerosol Medicine and Pulmonary Drug Delivery. 33(0):1-9 (2020). 9. Longphre MV, Burmeister Getz E and Fuller R. Clinical Bioequivalence of OT329 Solis and Advair Diskus in Adults with Asthma. Annals of the American oracic Society. 14(2):182-189 (2017). 10. Burmeister Getz E and Carroll K. Pharmacokinetic Bioequivalence of Two Fluticasone Propionate/Salme- terol Dry Powder Inhalers, OT329 Solis, and Advair Diskus. Chest. 152(4):A768 (2017). 11. A $442M Failure: After Years of Work and an FDA Rejection, Novartis Calls It Quits on Advair Copy. Fierce Pharma. Eric Sagonowsky. January 29, 2020. development-and-fda-rejection-novartis-calls-it-quits- advair-generic-and-takes. 12. Finished Product Monographs in the European Pharmacopoeia. http://www.pharm- an-pharmacopoeia-0. June 2, 2014. 13. United States Food and Drug Administration. Harmonizing Compendial Standards With Drug Application Approval Using the USP Pending Mono- graph Process Guidance for Industry Draft Guidance. July 2019. 14. United States Pharmacopeia. Guideline for Submit- ting Requests for Revision to USP–NF General Infor- mation for All Submissions G1.05-00 Page 1. Effective Date: 04/29/2016. 15. Lu D, Lee SL, Lionberger RA, Choi S, Adams W, Caramenico HN, Chowdhury BA, Conner DP, Katial R, Limb S, Peters JR, Yu L, Seymour S and Li BV. International Guidelines for Bioequivalence of Locally Acting Orally Inhaled Drug Products: Similarities and Differences. The AAPS Journal. 17(3):546-557 (May 2015). 16. García Arieta A. A European Perspective on Orally Inhaled Products: In Vitro Requirements for a Bio- waiver. Journal of Aerosol Medicine and Pulmonary Drug Delivery. 27(6):419-429 (2014). https://doi. org/10.1089/jamp.2014.1130. 24 June 2020 Inhalation

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