UCM261528碳酸司维拉姆仿制药人体生物利用度及等效性指导原则-FDA.pdf

Contains Nonbinding Recommendations Draft Guidance on Sevelamer Carbonate This draft guidance, once finalized, will represent the Food and Drug Administrations (FDAs) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the Office of Generic Drugs. Active Ingredient: Sevelamer carbonate Dosage Form; Route: Powder for suspension; oral Overview: This draft guidance provides recommendations for the development of a generic drug product, sevelamer carbonate powder, using sevelamer carbonate as the active pharmaceutical ingredient (API). First, FDA provides recommendations for supporting a demonstration of API sameness. Second, FDA provides recommendations for demonstrating bioequivalence (BE) of this product. Recommendations for Demonstrating API Sameness: The API, sevelamer carbonate, is a polymeric drug substance. According to the labeling of the reference listed drug (RLD) (Renvela®), sevelamer carbonate has the same polymeric structure as sevelamer hydrochloride, in which carbonate replaces chloride as the counter ion. Because sevelamer hydrochloride is poly (allylamine hydrochloride) crosslinked with epichlorohydrin 1 , FDA encourages sponsors to follow the same synthetic route to manufacture the API. Otherwise sponsors should contact the Office of Generic Drugs to obtain concurrence if an alternative synthetic route is proposed, which may require characterizations in addition to the ones outlined in the current draft guidance to demonstrate API sameness.