Issue link: https://www.e-digitaleditions.com/i/1254974
Inhalation June 2020 23 The future of OIP industry is what we will make it Inhaled medications have many advantages over other routes of delivery, especially for locally acting drugs. It is in the best interest of all key stakeholders—patients, healthcare professionals and inhalation companies developing and marketing products as well as payors— to have these products accessible and affordable to all who need them. At the same time, it is necessary to con- tinue to reward companies and individuals who work with innovator products for their efforts and invest- ments that bring better inhaled medications to patients. Both innovator and generic companies would be well served with such greater certainty about regulatory exclusivity. In conjunction with new incentives, the innovator industry may invest more effort on funda- mentally new approaches to OIPs versus extension of patent protection for old products. Much of academic and industrial research could be redirected from bio- equivalence studies to investigations aimed at develop- ment of new OIPs with improved efficacy, safety and convenience for patients. All of these efforts should result in better respiratory healthcare. Approval of mul- tiple generic versions of OIPs would result in greater affordability and accessibility through lower pricing and availability in all segments of the US healthcare sys- tem as well as those of other countries. e incentives for innovators would both stimulate and accelerate development and approval of new valuable therapies. References 1. Forum of International Respiratory Societies. e Global Impact of Respiratory Disease. Second Edition. European Respiratory Society. 2017. 2. BIO, Biomedtracker, Amplion: Clinical Develop- ment Success Rates 2006-2015. https://www.bio.org. 3. Gonda I. Re-inventing Inhalers for the Digital Age. Respiratory Drug Delivery Europe 2019. 1:67-74 (2019). 4. Berger J, Dunn JD, Johnson MM, Karst KR and Shear WC. How Drug Life-Cycle Management Patent Strategies May Impact Formulary Management. e American Journal of Managed Care. January 20, 2017. https://www.ajmc.com/journals/supplement/2016/ how-drug-life-cycle-management-patent-strategies- may-impact-formulary-management/a636-article. It therefore seems much more meaningful for generic products to meet the same "reference product" CMC criteria that the innovator is using to release their batches to the market. Compendial product monographs should set the standards for generic product approval ere are already elements of legal framework in the US that could be adjusted to facilitate the process we are proposing: approval of generic products solely on the basis of in vitro tests in the form of compliance with product monographs, in conjunction with attractive concessions for innovators in return for providing the necessary product information in a timely fashion. e Hatch-Waxman Act, which was introduced to accelerate the introduction of generic products, rec- ognized the discrepancy between patent protection duration and length of new product development. To reflect that, it afforded increased regulatory exclusivity periods. 21 We believe that additional exclusivity (e.g., similar to that for biologics) or attractive regulatory incentives such as priority review vouchers, could be used to com- pensate innovators for the mandatory publication of their quality control methods and specifications and provision of reference standards to enable the compen- dial product monographs. is would require urgent implementation of the cur- rent regulatory 12,13 and compendial 14 efforts to have such monographs ready for use by the generic industry no later than five years prior to the anticipated first "legal" entry of a generic version of a product. The approval of the generic product would then be subject to the ability of the sponsor to demonstrate compliance with specifications for the product using these published compendial methods, both at release and during the stability studies, as well as evidence of GMP compliance of the product's manufacturing facil- ities. No additional evidence of "bioequivalence" in the form of in vitro or in vivo studies would be required for approval of the generic products. Marketing of such generic products would still only be possible under the existing patent laws applicable in the territory. The suggested path would only apply to products approved as "generic" (through an Abbreviated New Drug Application (ANDA) in the US), as opposed to products that use the same active pharmaceutical ingre- dient (API) but have substantially different formula- tions or routes of administration relative to the innova- tor's product (e.g., products approved under the 505(b) (2) regulatory path in the US). Join the discussion! We hope that this short opinion piece will stimulate construc- tive discussion. We invite readers to use the Inhaled Drug Delivery Specialist LinkedIn blog to participate: https:// www.linkedin.com/groups/69806/. We are also seeking pro- posals for participation at conferences to facilitate a vigorous exchange of ideas and paths to implement them.