• Publication Date: 06/01/2020
  • Author(s):
    Cipolla, David Gonda, Igor Rogueda, Philippe
  • Organization(s):
    Insmed, Inc. Merxin, Limited Respidex, LLC
  • Article Type: Technical Articles
  • Subjects: Device Design, Devices and Components, Industry Issues and Trends, Product Development/Formulation, Testing, Validation, and Regulatory Compliance
In this opinion article, the authors pose the question, “Can we improve accessibility and affordability of orally inhaled therapies while protecting incentives for the development of innovative products?” and invite readers to join a discussion.

It is in the best interest of all key stakeholders to have inhaled medications accessible and affordable to all who need them. At the same time, it is necessary to continue to reward companies and individuals who work with innovator products for their efforts and investments 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 fundamentally new approaches to OIPs versus extension of patent protection for old products. Much of academic and industrial research could be redirected from bioequivalence studies to investigations aimed at development of new OIPs with improved efficacy, safety and convenience for patients. All of these efforts should result in better respiratory healthcare. Approval of multiple generic versions of OIPs would result in greater affordability and accessibility through lower pricing and availability in all segments of the US healthcare system as well as those of other countries. The incentives for innovators would both stimulate and accelerate development and approval of new valuable therapies.

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