Sunrise, Florida, USA, October 15, 2026
TranspireBio Holdings Inc. has presented an industry perspective on the U.S. Food and Drug Administration’s (FDA) evolving bioequivalence framework for generic inhalation medicines at a joint FDA and Center for Research on Complex Generics (CRCG) workshop. Xian-Ming Zeng, Ph.D., Chief Executive Officer of TranspireBio, delivered the presentation during the workshop titled “Advancing Bioequivalence Frameworks for Inhalation Drug Products: Optimizing In Vitro, In Vivo, and In Silico Methods,” held on October 14–15, 2026, at the Universities at Shady Grove in Maryland. The event brought together regulatory authorities, academic researchers and pharmaceutical industry experts to discuss scientific approaches that could support more efficient development and evaluation of complex generic inhalation products. The discussion highlighted opportunities and practical challenges in applying innovative methods to demonstrate that generic inhaled medicines perform comparably to their reference products.
TranspireBio Shares Industry Perspective on FDA Guidance
During the workshop, Dr. Zeng presented an industry perspective on the FDA’s updated bioequivalence framework for generic inhalation drugs. His presentation addressed opportunities, challenges and practical considerations associated with implementing evolving scientific and regulatory approaches for complex inhaled medicines. Bioequivalence is a critical requirement in generic drug development. It helps establish that a proposed generic medicine delivers its active ingredient in a manner sufficiently comparable to the reference product, supporting confidence in its expected performance. Demonstrating bioequivalence can be particularly challenging for inhaled medicines because their performance depends on multiple factors, including formulation characteristics, aerosol particle size, device design and the amount of medicine deposited in the lungs. Conventional clinical studies may not always be the only suitable way to demonstrate equivalence. Depending on the product and applicable regulatory recommendations, developers may be able to use a combination of in vitro laboratory testing, in vivo studies and in silico modelling. These approaches can help characterize product performance and build a scientific case for comparability while maintaining appropriate quality and regulatory standards. The workshop provided a forum for stakeholders to discuss how these methods can be validated, interpreted and applied in generic inhalation product development. The objective was to encourage a shared understanding of scientific evidence and regulatory expectations, rather than to announce a new approval or a change in requirements for any individual medicine.
Innovative Methods Could Support Generic Inhaler Development
The FDA/CRCG workshop examined methods for evaluating metered-dose inhalers (MDIs) and dry-powder inhalers (DPIs), including products with different formulation characteristics. Discussions covered particle size distribution, dissolution testing, particle morphology and approaches to pharmacokinetic assessment. These analytical methods are important because inhaled medicines must deliver an appropriate dose to the respiratory tract. Particle size distribution can influence where aerosolized drug particles deposit in the lungs, while formulation and device characteristics can affect aerosol generation and delivery. Reliable laboratory methods can therefore provide important evidence when comparing a generic inhaler with its reference product. The programme also explored potential alternatives and refinements to charcoal-block pharmacokinetic studies, as well as possible approaches to demonstrating bioequivalence for additional product strengths. In vitro, in vivo and computational methods may complement one another, allowing developers to build a more comprehensive evidence package tailored to the characteristics of a particular inhalation medicine. However, the suitability of any approach depends on the product, the quality of the supporting evidence and applicable FDA recommendations. Alternative methods must be scientifically justified, appropriately validated and acceptable within the relevant regulatory framework. The use of innovative testing does not remove the requirement to demonstrate that a generic product meets applicable standards for quality, safety and performance.
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TranspireBio Team Contributes to Regulatory Discussions
In addition to Dr. Zeng’s presentation, TranspireBio Chief Scientific Officer Abhishek Gupta, Ph.D.; Chief Medical Officer Mark Lepore, M.D.; and Director of Research and Development, Formulation Development, Chirag Shah, M.Pharm., were invited to participate as panelists. Their involvement brought expertise in clinical development, medical assessment and inhalation formulation research to the discussions. In addition to Dr. Zeng’s presentation, TranspireBio Chief Scientific Officer Abhishek Gupta, Ph.D.; Chief Medical Officer Mark Lepore, M.D.; and Director of Research and Development, Formulation Development, Chirag Shah, M.Pharm., were invited to participate as panelists. Their involvement brought expertise in clinical development, medical assessment and inhalation formulation research to the discussions. The company said engagement among regulators, researchers and industry participants could help translate rigorous scientific methods into more efficient development pathways and potentially broaden access to high-quality inhaled medicines. The FDA/CRCG workshop highlights the growing role of evidence-based analytical and modelling methods in complex generic drug development. Continued collaboration among regulatory authorities, academia and pharmaceutical companies will be important in refining bioequivalence approaches while maintaining the standards needed to ensure that generic inhalation therapies perform reliably for patients.
Source: TranspireBio press release
