Is the generic drug of ensidipine as effective as the original drug?

Enasidenib's approved indications are mainly for adult patients with relapsed or refractory acute myeloid leukemia (AML) who have isocitrate dehydrogenase 2 (IDH2) mutations. Such patients often experience disease progression despite receiving standard chemotherapy or hematopoietic stem cell transplantation, and their prognosis is poor. After the presence of R140 or R172 point mutations is confirmed through genetic testing, ensidipine can be used as a precise treatment to help restore the differentiation function of abnormal hematopoietic cells, delay the progression of the disease and improve the quality of life. Due to its convenience of oral administration, ensidipine is particularly suitable for elderly or comorbid patients who cannot tolerate intensive chemotherapy.

Regarding the effectiveness of generic drugs, international drug regulatory agencies currently generally require generic drugs to be consistent with original drugs in terms of active ingredients, dosage specifications, dosage forms and bioequivalence. This means that qualified generic drugs should have the same therapeutic effect as the original drug in terms of chemical structure, pharmacokinetics and clinical efficacy. In overseas markets, the common specifications of original-grade ensidipine include 50 mg 30 tablets and 100 mg 30 tablets, but they are expensive. The price of a single box can be as high as more than 30,000 yuan. The specific price will also change with exchange rate fluctuations.

In contrast, some generic drugs produced overseas, such as Ensidipine 50mg*30 tablets from Lucius Pharmaceutical Factory in Laos, are sold for only about 1,000 yuan, and their active ingredients are basically the same as the original drugs, which is a great economic advantage for patients who take the drug for a long time. Although the price gap is significant, as long as the generic drug passes strict quality control and bioequivalence evaluation, its clinical efficacy and safety should be no different from the original drug.

When choosing generic drugs, patients should ensure that the source of the drug is regular, and the switching plan should be evaluated by a doctor to avoid affecting the efficacy due to substandard drug quality or mismatched dosage. For patients who have stably benefited from the drug, it is still necessary to continue to monitor changes in blood levels and condition after switching to generic drugs to confirm the continuation of the therapeutic effect.

Reference materials:https://www.idhifa.com/