The US Food and Drug Administration (FDA) has made one of the most commonly prescribed cancer drugs in the market generic after both the brand-name and generic drug maker has settled its dispute over patents last year.
The FDA has approved the application of Sun Pharmaceutical Industries Limited subsidiary based in India to produce a generic version of Gleevec (imatinib mesylate), which is a commonly prescribed medication for patients who are diagnosed with chronic myeloid leukemia (CML). Also known as chronic myelogenous leukemia, it is gradually progressive, although it can turn into an acute type.
It occurs mostly among adults, but the treatment for both children and adults are the same. Gleevec, which is produced by Novartis, is considered to be better performing than interferon, which used to be the most prescribed medication, according to American Cancer Society. It can also be used to treat acute lymphoblastic leukemia.
The subsidiary is expected to produce generic version of Gleevec in both 100 and 400 milligrams, which can be taken once a day. They can begin distributing the cancer drug by the first week of February next year. After six months, the FDA will review and determine if other generic drug makers will be allowed to make their own. One of the possible contenders is Dr Reddy's Laboratories Limited, which has also reached an agreement with Novartis over patents. Analysts believe they may begin launching in the last quarter of 2016.
With the introduction of the generic pill, prices of the cancer drug are expected to fall. Currently, Gleevec treatment can cost at least $10,000 a month. Novartis is now offering to cover as much as $30,000 a year while patients who are not under government insurance or not paying in cash can co-pay $10 using a private insurance card the brand name drug company is offering.
