Drugs

Biopharmaceutical Classification Biowaivers Guidance

FDA has issued a draft International Conference for Harmonization guidance, M9 Biopharmaceutics Classification System-Based Biowaivers, with recommendations to support the biopharmaceutics classification of drug substances and the BCS (biopharmaceutics classification system)-based biowaiver of bioequivalence studies for drug products. The document says biowaivers may be used to demonstrate bioequivalence, for example, between products used in early clinical development through commercialization, for line extensions of the same pharmaceutical form of innovator products, in applications for generic drug products, and post-approval changes that would otherwise require in vivo bioequivalence evaluation, in accordance with regional regulations.

The guidance says the BCS-biowaiver approach is intended to reduce the need for in vivo bioequivalence studies by providing a surrogate for in vivo bioequivalence. It says that in vivo bioequivalence studies may be exempted if an assumption of equivalence in in vivo performance can be justified by satisfactory in vitro data.

“The BCS-based biowaiver is only applicable to immediate release, solid orally administered dosage forms or suspensions designed to deliver drug to the systemic circulation,” it says. “Drug products having a narrow therapeutic index are excluded from consideration for a BCS-based biowaiver in this guidance. Fixed dose combination products are eligible for a BCS-based biowaiver when all drug substances contained in the combination drug product meet the criteria as define … [in] the guidance.”

Gupta Raises Concerns About Overton’s Independence, Ideology

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FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome