Also known as follow-on biologic or subsequent entry biologic, a biosimilar is basically a medical product that copies an original one manufactured by a different company, usually with high molecular complexity, usually permitted when the patent to the original medicine expires; now, the FDA biosimilar approval could carve the path for new developments on the area.
As the first FDA biosimilar approval comes to light with Zarxio, it's important to note that these kind of medicines, called biologics, could be sensitive to changes in the process of manufacturing, as the laboratories who make the copies don't have the cell bank of the creators, but only the drug itself - due to this, many have raised concerns that biosimilars could act differently than the original products.
As the Food and Drugs Administration states on its website, original biological products will often deride from a living organism, and follow-on has to contain the same active components, only varying in clinically inactive components, as the FDA biosimilar approval depends on the new medication to act exactly the same way as the previously accepted product.
According to The New York Times, the new FDA biosimilar approval is big news in health, as it paves the way for other medication to enter the market, thus helping a lot of people who need costly treatment to regain their health - basically, the more there are, they complex drugs will be more attainable and less expensive.
Pharmaceutical company Sandoz produces Zarxio, and it was created to help prevent infections in those cancer patients that are receiving chemotherapy, a treatment that leaves patients weak and prone to infection; it's based on Amgen's Neopogen, the reference drug needed for the FDA biosimilar approval.
According to The Wall Street Journal, the US spends $376 billion in drug spending yearly, an incredible that would potentially greatly increase with the new FDA biosimilar approval, as it means that other biosimilars will come as well to lower costs.
