CRED 8 Presentations

03/07/2024

Biopharmaceutics Classification System (BCS)-based Biowaiver

• If an active substance is highly soluble, it is reasonable to expect that it will not cause any bioavailability problems if, in addition, the dosage system is rapidly dissolved in the physiological pH range and the excipients are known not to affect bioavailability • BCS-based biowaiver is restricted to highly soluble drug substances with known human absorption and considered not to have a narrow therapeutic index. Applicable to immediate release, solid oral pharmaceutical forms. • Immediate release - Where more than 85% of the drug is dissolved within 15 minutes (time for gastric emptying), as shown in multi media dissolution profiles

The Organisation for Professionals in Regulatory Affairs

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Hybrid

Art 10(3) – Hybrid • Similar to a Generic, but with a difference to the reference product:

• Change in the active substance(s) • Change in therapeutic indications • Change in pharmaceutical form • Change in strength • Change in route of administration • Modules 1, 2 & 3 (complete quality data)

• Modules 4 & 5 - Appropriate non-clinical & clinical studies required e.g. if different indication or posology or if bioequivalence is not used. If a different active (such as the salt) evidence that efficacy or safety is unchanged • The strict definition of a generic medicinal product in not met • Where bioequivalence cannot be demonstrated through bioavailability studies • Rely in parts on the dossier of the reference medicinal product and the results of appropriate own non-clinical and/or clinical studies

The Organisation for Professionals in Regulatory Affairs

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