Sandoz, a Novartis company, is a “world leader in generic pharmaceuticals.” Generic drugs are officially described as non-brand products, which are expected to be comparable to the brand/reference drug product in its dosage form, quality, strength and intended use. However, complaints have been lodged against certain generic drugs, which have been shown to have different bioequivalencies (the rate and extent to which a drug is absorbed) than the branded drug, for example. This in turn can affect how much and how long a drug stays active in an individual’s system and thus the ultimate effect and usefulness of the drug.
Zarxio is biologically similar to a brand drug known as Neupogen, which is made by Amgen and has been used in Europe since 2009. Until recently, however, the New York Times reports that there was “no regulatory pathway” by which to bring “approximate copies of drugs” to market.
This situation changed in January when a panel of scientists unanimously voted to approve the use of Zarxio in the U.S. This was a landmark decision in part because biosimilar drugs mimic a biologic medical product, but unlike small-molecule drugs, biologics possess significant molecular complexity and are especially sensitive to manufacturing processes. Thus, they are believed to be more difficult to “mimic” than their small-molecule counterparts.
Still, Dr. Margret A. Hamber, the commissioner of the FDA, said in a statement “Biosimilars will provide access to important therapies for patients who need them.” This will enable millions of Americans to afford potentially lifesaving drugs. Beyond saving the lives of patients, Express Scripts has estimated that the approval of Zarxio will potentially save the US $5.7 billion in drug costs over the next decade and if other biosimilars are approved, over $200 billion.
Though the physicians who approved the use of Zarxio did not see any differences between this biosimilar and the brand drug, there may still be challenges in convincing physicians to use the non-brand drug. As well, biosimilars may run into the same problems as certain small-molecule drugs, which do not always mimic the effects of the brand drug. For now, life-saving therapies will likely be available to more people in the coming months, which is a positive development.
It has been some time Zarxio has come onto the US drug market. It hasn’t made a large impact as far as the world outside the medical community. What have you heard about Zarxio? Has it been important in your life?