Is Forxiga generic same as solvate-modified drug?
By Lee, Tak-Sun | translator Byun Kyung A
21.03.29 16:23:39
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Solvate-modified drug wins preferential sales right, categorizing them the same means delaying generic release by 9 months
Salt-modified drug is not considered the same, but solvate modification has no standard set by MFDS
¡ãA product image of Forxiga
Pharmaceutical companies developing generics of an antidiabetic Forxiga are concerned that the products would get struck by receive sales ban due to preferential sales rights. The related criteria are not clarified enough for companies to predict the result. According to the pharmaceutical industry sources on Mar. 29, the companies are hectic developing generic drugs sharing the same active pharmaceutical ingredient (API) with AstraZeneca¡¯s antidiabetic treatment, sodium-glucose co-transporter-2 (SGLT2) inhibitor Forxiga (dapagliflozin propanediol hydrate).
So far none of the companies have requested for approval review, but seven bioequivalence tests were approved to this date.
Lee, Tak-Sun(hooggasi2@dailypharm.com)
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