On February 1, 2016, there was a commercial launch of the generic version of imatinib mesylate (Gleevec) which is approved for CML patients by the FDA. As the first to file for generic marketing in the US, Sun Pharmaceuticals was given a 6-month market exclusivity, and it has since expired in August 2016. There are now two other imatinib generic manufacturers – Apotex and Teva, who have been given market approval by the FDA. Moving forward, more manufacturers will gain approval and increase the production of generic imatinib.
All generic drugs must pass a bio-equivalency test (to be considered bioequivalent to the innovator drug), meaning they must deliver the same amount of active ingredients into a patient’s bloodstream in the same amount of time as the innovator drug (Gleevec). The acceptable bioequivalent range is 80 to 120%. The generic imatinib must be comparable to the brand name Gleevec in regards to dosage, strength, route of administration, quality and efficacy, and intended use. Although up to three manufacturers are making the generic imatinib, the products are still only approved for CML. The patent for the GIST indication will not expire until 2020. Therefore, you may choose to talk with your doctor about remaining on the brand Gleevec. Simply refer to the distribution laws for your state to prevent substitution.
Just a tip (please note: we are not endorsing any of the generic manufacturers), if you are getting the generic drug, and it’s working for you, please stay with the manufacturer of that generic just to make sure you maintain consistency in quality. We also advise you to talk with your pharmacy regarding your insurance or out-of-pocket costs before switching to a generic. Based on our market research, we have found that the cost difference between brand and generic to be between 20-30%, so it will be helpful to learn your options.