Bioequivalence Innovations for Generic Oral Products

The field of generic oral drug products continues to evolve leading to innovative bioequivalence (BE) approaches when conventional in vivo bioequivalence study designs may not be feasible. In response to these evolving complexities, this workshop is designed to address the latest advancements and regulatory challenges in the field, offering a unique platform to engage with all relevant parties, share knowledge, and contribute to the evolution of generic oral product development and regulatory assessment.

• Virtual Attendance is ideal for those who wish to access expert presentations and panel discussions remotely, eliminate travel requirements, and have the flexibility to engage with content in real time or on demand.

• In-Person Attendance is best for participants seeking high-level engagement through collaborative small group working sessions, direct interaction with experts from industry, consulting groups, academia and FDA, and immersive learning focused on real-world challenges and problem-solving.

Additional information can be found on the CRCG site: https://www.complexgenerics.org/education-training/bioequivalence-innovations-for-oral-generic-products-biowaivers-bridging-and-generic-development-for-oncology-and-discontinued-products/

Info: This session will highlight how FDA and industry approach bioequivalence decision-making for oral oncology products when ethical constraints, patient feasibility, and limited study options require the use of alternative evidence and clearly defined decision thresholds.

Info: This session examines how nitrosamine-driven reformulation should be evaluated within BE frameworks, emphasizing scientific justifications, risk-based assessment, and when alternative BE evidence is appropriate, particularly for BCS IV immediate release and modified release products.

Info: This session frames discontinued RLDs and unavailable reference standards as a barrier to generic access, highlighting the public-health impact, regulatory constraints, and alternative approaches to resolve the problems.

Info: In this collaborative session, participants will join small-group discussion tables facilitated by FDA, industry, consulting groups and academic experts. In-Person Attendees will engage in discussions related to challenges and opportunities of bioequivalence approaches for oral oncology products, nitrosamine-driven reformulation and bioequivalence, and developing generic products when a reference standard is unavailable. Attendees will engage in guided discussions, consensus mapping, and reporting of actionable research or policy recommendations. Direct interactions with experts from FDA, industry, consulting groups and academia will be fostered.

Info: This session highlights when dissolution data can credibly transition from a quality control tool to regulatory evidence for bioequivalence, focusing on biorelevant/predictive dissolution, discriminating capabilities of the testing media/method, integration with modeling, evidence sufficiency, and common dissolution-based BE arguments.

Info: This session explores strategies for achieving regulatory acceptance when using alternative approaches to establish bioequivalence in challenging scenarios.

Info: In this collaborative session, participants will join small-group discussion tables facilitated by FDA, industry, consulting groups and academic experts. In-Person Attendees will engage in discussions related to the solutions (e.g., biopredictive dissolution and regulatory acceptance of alternative approaches) to address the challenges discussed on Day 1. Attendees will engage in guided discussions, consensus mapping, and reporting of actionable next steps. This session will foster direct interactions with experts from FDA, industry, consulting groups and academia.

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Host or Publisher Center for Research on Complex Generics