The pharmaceutical industry is preparing to experience some major changes within the coming weeks. Zarxio is a drug that reduces infections caused by chemotherapy, and it is about to be the very first biosimilar drug to be sold in the United States. This drug is destined to revolutionize the U.S. pharmaceutical industry.
A biologic medical product is a complex drug that has been created in living organisms. According to the FDA, they are isolated from a variety of natural sources: human, animal or microorganism. Biosimilars are basically a copy of an original product; they are generic-like alternatives.
Biosimilars are not a new alternative. In fact, biosimilars have been offering millions around the world affordable lifesavings treatments for some time now. Just like generic drugs, biosimilars have been offering millions the chance to have the same biological effects while also taking advantage of a much cheaper alternative. It is only in the United States that they have not been available due to the lack of regulatory approval.
With biosimilars making their way to the U.S., the amount of money the U.S. can save in its spending is now a big topic. According to a 2014 Rand analysis, the use of biosimilars will reduce the U.S. spending on biologics by $44.2 billion through the year 2024. Actual savings could range from $13 billion to $66 billion. However, all of these savings completely depend on the FDA regulations that unfold.
These changes will also help the federal government with the growing number of baby boomers that are now entering Medicare and low-income Americans who rely on Medicaid. While the Congressional Budget Office estimated the amount of savings the federal government would experience with biosimilar products back in 2010 when the Affordable Care Act was signed into law, it is just now – five years later – that the FDA is approving the first biosimilar product, Zarxio.
While there is still some uncertainty concerning the FDA’s regulation of biosimilars, pharmaceutical companies are encouraged by the approval of Zarxio and have already submitted applications to the FDA for several other biosimilar products. It seems it is only a matter of time before biosimilars become a big part of the pharmaceutical industry in the U.S.
What does this mean for those who are ready to get involved with this new market? There may be a certain level of risk and uncertainty, since the FDA is still in the process of figuring out regulations and naming conventions. For businesses in need of funding and payment processing solutions, the best, safest and most hassle-free choice will most likely be a pharmacy merchant account; the majority of merchant account providers specialize in industries that might otherwise be labeled as “high risk” by traditional lending sources that are concerned about the present uncertainty surrounding this industry.