Many people struggling with chronic medical conditions have found relief with biopharmaceuticals. You may be taking a biopharmaceutical without even realizing it. Common biopharmaceutical names you may have heard of include adalimumab (brand name: Humira), infliximab (brand name: Remicade) and trastuzumab (brand name: Herceptin). Biopharmaceuticals can be beneficial for a wide range of medical issues, including diabetes, psoriasis, colitis, Crohn’s disease, multiple sclerosis, arthritis, as well as breast, lung, and colon cancers. However, they can also be very expensive, with Humira costing up to $30,000 per year. For some people using biopharmaceuticals, there may be an equally effective, lower-cost alternative: biosimilars.
Biopharmaceuticals are made from living material such as animal cells, fungi, and bacteria, unlike most medications that are made from chemicals. This process of preparing a biopharmaceutical is complex, lengthy, and costly. To create a biopharmaceutical, living cells are grown in specialized facilities under very specific and carefully controlled conditions. The cultivation of these cells can take weeks, during which they are closely monitored. After the cells are grown, scientists extract a protein from them to use in making the biopharmaceutical, which is then purified to obtain the final product.
Biosimilars are biological medications also prepared from living tissues and designed based on an existing biopharmaceutical (referred to as a reference product). Their preparation process involves less interaction, making them more cost-effective. Despite the lower cost, biosimilars are required to demonstrate the same efficacy and safety as the original biopharmaceuticals. The approval process for biosimilars by the FDA involves careful analysis and comparison to ensure they meet the same high standards required for reference products before approval.
Patent disputes play a role in the limited availability of biosimilars in the market, as companies producing biosimilars must wait for the expiration of patents held by biopharmaceutical manufacturers before their versions can be approved. Despite the challenges, biosimilars are becoming increasingly common in clinical practice for various medical conditions, offering a more cost-effective alternative to biopharmaceuticals without compromising effectiveness. If you’re living with a medical condition that can be managed with biopharmaceuticals, biosimilars may be a more affordable option for you. Understanding the preparation and approval process of biosimilars can help you make an informed decision about your treatment.
