Biosimilars are on the way in America
Thursday, June 15, 2017
The general public may not fully understand the importance and potential benefits of biosimilars, but this class of agents is slowly gaining attention as therapeutic options for chronic or life-threatening conditions and disease states.
Many patients in the U.S. are not aware of biosimilars and their capabilities, because biosimilars have not actually existed on American shores for long. By the time the first biosimilar was approved in the United States around the summer of 2015, Europe had already approved 19.
Biosimilars allow for lower-cost versions of biologics to be made available to the public. These pharmaceutical drugs are specifically designed to have active properties that are comparable or similar to drugs that have been already been licensed for treating conditions such as anemia, diabetes or cancer, to name a few.
Zarzio, which helps cancer patients receiving chemotherapy produce white blood cells, was the first approved biosimilar in the U.S. to be considered therapeutically equivalent to an existing biologic, Neupogen. This has opened the door for other biologics to follow suit.
As the prevalence of cancer diagnoses continues to increase, it is becoming increasingly important for researchers to identify novel agents for treatment and make these available to to the public. And the area of cancer treatment has witnessed a great milestone with the use of biologics.
According to a Heritage study published in January in the Journal of the American Medical Association, a potential biosimilar was able to demonstrate equivalency to traztuzumab (Herceptin) with regard to the treatment of HER2-positive metastatic breast cancer and HER2-positive gastric cancer.
The initial response rates that were displayed during the randomized clinical trial by this biosimilar showed promise related to not only allowing for greater access to this therapy for patients, but also for the potential to improve patients' and providers' understanding of the role and value of biosimilars in treating chronic conditions.
In the future, additional trials will be needed to fully assess the safety and potential short- and long-term outcomes associated with the use of this new biologic. Only time will tell if this agent will offer the same therapeutic outcomes as Herceptin and other agents or if it will fail to produce the desired outcome.
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