Preguntas sobre biosimilares – HealthyWomen

Biosimilars are medications modeled after another type of medication called biopharmaceuticals. Both options can be used to treat a range of medical issues, including autoimmune disorders such as rheumatoid arthritis (RA) and some types of cancer. Biopharmaceuticals are made from a natural source, such as plant or human cells, and biosimilars are prepared in the same way. To receive FDA approval, a biosimilar must demonstrate that it works the same way and is as safe as the biopharmaceutical it was designed after (referred to as a reference product). The process of preparing a medication from living materials is complex and lengthy, which is reflected in the price of biopharmaceuticals. For example, biopharmaceuticals used to treat RA can cost up to $36,000 per year. Since biosimilars are based on a biopharmaceutical, their preparation is easier and cheaper, making them more affordable for patients. On average, biosimilars cost about a third of what reference products cost. If you are living with a medical condition that can be managed with biopharmaceuticals, biosimilars may be a more affordable alternative that works just as well. Here are some questions you can ask your healthcare provider (HCP) about biosimilars: What experience do you have with biosimilars? This is likely the first question you should ask because your healthcare provider may not have the knowledge or experience to answer your questions about biosimilars. But they may be able to refer you to someone who does. Are there biosimilars available for my condition? Biosimilars can be used to treat or manage many chronic medical conditions, including diabetes, colitis, Crohn’s disease, psoriasis, arthritis, and multiple sclerosis. They are also used to treat breast, lung, and colon cancers. If you have one or more of these conditions, there may be useful biosimilars for you. And if you already use a biopharmaceutical to manage a medical issue, a biosimilar may be a more affordable option. This price difference could be particularly helpful for women, as they are more likely than men to deal with chronic medical conditions. Biosimilars could also be more affordable alternatives for women needing treatments they may not otherwise be able to access, such as expensive breast cancer treatments. Will my health insurance cover a biosimilar? The list of biosimilars (if applicable) covered will depend entirely on your insurance plan and your specific medical circumstances (your diagnosis, if you have tried other treatments, etc.). For example, some insurance companies may choose to cover certain biopharmaceuticals instead of biosimilars because they have agreements with the manufacturers of these biopharmaceuticals. Healthcare providers are not necessarily insurance experts, but most have helped patients navigate the process of identifying which medications are covered. Read: Obstacles of Biosimilars >> Is a biosimilar as effective as a biopharmaceutical? A biosimilar must demonstrate that it works in the same way, and as well, as the reference biopharmaceutical it was based on before it can receive FDA approval. Your healthcare provider can provide you with information on how well the biosimilars they recommend for you work. How do I safely switch from a biopharmaceutical to its corresponding biosimilar? Since biosimilars are similar, but not identical, versions of biopharmaceuticals, switching from a biopharmaceutical to a biosimilar is not as simple as substituting a generic version of a drug for the brand-name version (biosimilars and generics are copies of FDA-approved drugs, but biosimilars are only similar to their reference biopharmaceuticals because they are large molecules made from living elements, while generics are identical to their corresponding brand-name drugs because they are small molecules made from chemicals). However, a recent review of several studies involving 5000 patients who switched between biopharmaceuticals and biosimilars found no differences in safety between the two options. Your healthcare provider can guide you through the process and make the necessary checks to ensure that your body responds well to the switch. How does the biosimilar interact with other medications I am currently taking? Whenever you consider taking a new medication, it is important to discuss with your healthcare provider how this medication may interact with the ones you are already taking. Bringing a list of all medications you take (including over-the-counter medications such as allergy medications and supplements) can be helpful for your healthcare provider to clearly identify potential interactions with biosimilars. What are the risks and side effects of the biosimilar you are prescribing? The FDA has strict safety standards for medications, and biosimilars must demonstrate that they are safe before they are approved. But all medications have some level of risk or the potential to cause side effects. Much depends on the specific medication and your current medical situation, not just the condition you are considering treating with a biosimilar, but also any other medical conditions you have. A biosimilar will have the same risks or side effects as the biopharmaceutical it was based on. Your healthcare provider can help you understand the potential risks and side effects of biosimilars based on your particular medical situation. Empowering yourself to get answers It’s important to note that not all providers are experts on biosimilars, and that’s okay. If your healthcare provider cannot answer these and other questions, you should feel empowered to ask for a referral to someone who can. This educational resource was prepared with the support of Sandoz.