Especially in an election year in which Americans’ finances are a hot topic, the cost of pharmaceuticals is all over the news. Likewise, every now and then, the topic of Biosimilars is raised by the media. This type of medical product can be used as a substitute for some Biologic drugs and offers hope for many Americans who have to take certain expensive medications.
A Biologic is a protein that is often made by using recombinant DNA. Biologics are usually very large and complex molecules, and are made inside of living systems. Examples of some FDA-approved Biologic agents include human growth hormone, insulin, interferon alfa, pancreatic enzymes and human papillomavirus major capsid proteins. Biologics typically cost a significant amount to create, meaning the cost to patients can also be significant. Furthermore, typical Biologics are used to help treat certain debilitating and life-threatening diseases, meaning that they are very necessary for the livelihood – and very often for the survival – of the patients who need them. Unfortunately, the price of administering a Biologic can range between $15,000 and $150,000 a year for a patient, according to information from MedScape.
A Biosimilar product is similar to the Biologic it is mimicking, with no huge clinical differences. Studies must support clinical likenesses regarding potency, safety and purity. The BPCI Act, or Biologics Price Competition and Innovation Act, was passed as part of the Affordable Care Act on March 23, 2010 as an effort to bring costs down on crucial medications for certain diseases, including many cancers. Biosimilars will be interchangeable with certain FDA approved pharmaceuticals, but may have much smaller price tags.
Biosimilars could be a very important key in reducing healthcare costs for individuals who must take certain prescription medications. Several pharmaceutical companies are already in the process of developing Biosimilar drugs.
The American Journal of Managed Care states that Biosimilars for Humira, Enbrel, Neulasta, Remicade and Rituxan could be on the market within four years from Sandoz, a leading pharmaceutical company. Amgen has 9 Biosimilars that are still being developed. Merck has 4 Biosimilars under development.
Although many experts foresee the development of Biosimilars as a way for patients with certain serious ailments to significantly reduce their prescription costs, many Americans have their doubts. Some argue that, at least in the beginning years of Biosimilars’ production and implementation, development costs will be high and that savings will be modest when compared to a Biologic. However, further down the road as Biosimilar production becomes more prevalent, those costs could decrease, offering a savings to those patients suffering from some debilitating and life-threatening diseases.
