CROSSJECT : Biowaiver bioequivalence guideline subcutaneous injection

Jato_makoto

05 févr. 2025 •13:29

"Biowaiver Bioequivalence Guidelines
The European Medicines Agency (EMA) and the Food and Drug Administration (FDA) have guidelines for biowaivers in the context of bioequivalence studies, which can apply to subcutaneous injections. Here’s an overview based on the available information:

EMA Guidelines: The EMA has guidelines on the investigation of bioequivalence, which include considerations for biowaivers. For subcutaneous injections, the EMA generally accepts biowaivers for products that meet certain criteria, such as having the same active substance and excipients, and no expected impact of excipients on bioavailability. The EMA's guidelines are detailed in the "Guideline on the Investigation of Bioequivalence" (Rev.1), which was adopted on 01/08/2010.
ICH M13A: As of January 25, 2025, the ICH M13A guideline on bioequivalence for immediate-release solid oral dosage forms will supersede applicable parts of the EMA guideline related to bioequivalence study considerations and data analysis for non-replicate study designs. However, this does not directly affect subcutaneous injections, which are covered under different sections of the guidelines.
FDA Guidelines: The FDA also has guidelines for biowaivers, which can apply to certain dosage forms, including subcutaneous injections. The FDA's guidance document, "Demonstrating Bioequivalence for Soluble Powder Oral Dosage Form Products and Type A Medicated Articles Containing Active Pharmaceutical Ingredients Considered to Be Soluble in Aqueous Media," provides additional information on soluble powders and some Type A medicated articles that may be eligible for a biowaiver. For subcutaneous injections, the FDA generally requires that the excipient composition be qualitatively the same and quantitatively very similar, with minor exceptions for buffer agents, antioxidants, and preservatives.
Jurisdictional Differences: In jurisdictions like Japan and Taiwan, biowaivers are not acceptable for certain dosage forms, including subcutaneous injections. However, in most other jurisdictions, biowaivers are possible for subcutaneous solutions if the same oily vehicle is used and if the differences in excipients are scientifically justified.
In summary, biowaivers for subcutaneous injections are generally accepted by regulatory bodies like the EMA and FDA, provided that certain criteria are met regarding the formulation and excipients