Making cancer treatment accessible for everyone

Azacitidine is a chemotherapy drug used to treat Myelodysplastic Syndrome, a type of cancer where blood cells either function poorly or aren’t properly formed. A proven form of treatment, azacitidine helps the bone marrow produce normal blood cells and destroys abnormal ones. However, the compound is chemically unstable, degrading rapidly in the presence of water, even at low temperatures. This makes developing a stable product tricky business.

In the early 2000s, we decided to develop a generic version of Azacitidine, which until then was only available via the innovator. Our scientists conducted structured experiments to resolve the drug’s chemical instability. Once that was achieved, it was possible to produce it on a commercial scale at a fraction of the cost.

The next step was to prove that our version was similar to the innovator company’s medicine. This required a complex human bioequivalence study, which would assess the in-vivo biological equivalence of the two products. But this proved to be a great challenge. Although we reached out to around 500 hospitals to find patients to run this study, we were not successful. MDS is a rare cancer and patients suffering from it are vulnerable. This meant that most of them were not cleared for trials.

When we presented these facts, the FDA approved an in-vitro bioequivalence study, by which we proved that our product and the innovator drug are the same through wide-ranging lab-generated data. It was good enough to convince the authorities, and we were granted a biowaiver. Dr. Reddy’s became the first company in the world to launch the generic Azacitidine (injection).

Today, nearly a third of MDS patients in the US use our version of Azacitidine. In 2017, Dr. Reddy’s generic Azacitidine was approved in Canada — we were first to market again. In November 2020, we successfully launched Azacitidine in Italy.

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