Biosimilars are medications modeled after other types of medications called biopharmaceuticals. Both options can be used to treat a range of medical problems, including autoimmune disorders such as rheumatoid arthritis (RA) and some types of cancer.
Biopharmaceuticals are prepared 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 be shown to work in the same way and as safely as the biodrug on which its design was based (called a reference product).
Preparing a drug from living materials is a complex and long process and the price of biopharmaceuticals reflects that. For example, biopharmaceuticals used to treat RA can cost up to $36,000 a year.
Since biosimilars are based on a biodrug, they are easier and cheaper to prepare, which means they are cheaper for patients. On average, biosimilars cost about a third of what reference products cost.
If you live with a medical condition that can be managed with biopharmaceuticals, biosimilars may be a more affordable alternative that will work 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 probably the first thing you should ask because your healthcare provider may not have the knowledge or experience to answer your questions about biosimilars. But you can refer to someone who does.
Are there biosimilars available for my disorder?
Biosimilars can be used to treat or manage many chronic medical disorders, 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 disorders, there may be biosimilars useful for you. And if you already use a biopharmaceutical to manage a medical problem, a biosimilar could be a more affordable option.
This price difference could be particularly helpful for women, since they are more likely than men to deal with chronic medical conditions. Biosimilars could also be more expensive alternatives for women to treatments they couldn’t get otherwise, such as expensive breast cancer treatments.
Will my health insurance cover a biosimilar?
The list of biosimilars (if applicable) that are covered will depend entirely on your insurance plan and your particular medical circumstances (your diagnosis, whether you have tried other treatments, etc.). For example, some insurance companies may choose to cover certain biodrugs rather than biosimilars because they have agreements with the manufacturers of these biopharmaceuticals.
Health care providers are not necessarily insurance experts, but most have helped patients through the process of identifying which medications are covered.
Read: Obstacles of biosimilars >>
Is a biosimilar as effective as a biopharmaceutical?
A biosimilar must be shown to work in the same way, and as well, as the reference biopharmaceutical on which its design was based before it can receive FDA approval. Your healthcare provider can provide you with information about how well the biosimilars they recommend work for you.
How do I safely switch from a biodrug to its corresponding biosimilar?
Because biosimilars are similar, but not identical, versions of biodrugs, switching from a biodrug to a biosimilar is not as simple as substituting a generic version of a drug for the brand-name version (biosimilar and generic drugs are copies of drugs that have already received FDA approval, but biosimilars are only similar to their reference biopharmaceuticals because they are large molecules made from living things, while generic drugs are identical to their corresponding brand-name drugs because they are small molecules made from chemicals).
However, one recent evaluation of several studies involving 5000 patients switching between biodrugs and biosimilars did not identify any difference in safety between the two options. Your healthcare provider can guide you through the process and will do the necessary checks to ensure your body reacts well to the change.
How does the biosimilar interact with other medications I currently take?
Any time you consider taking a new medication, it’s a good idea to talk to your healthcare provider about how this medication might interact with those you’re already taking. Bringing a list of all the medications you take (including over-the-counter medications such as allergy medications and supplements) may be helpful so your healthcare provider can 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 drugs, and biosimilars must be proven safe before they are approved. But all medications have some level of risk or have the potential to cause side effects. Much depends on the specific medication and your current medical situation, not only 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 biodrug on which its design was based. Your healthcare provider can help you understand the possible risks and side effects of biosimilars based on your unique medical situation.
Feel empowered to get answers
It is important to note that not all providers are experts in biosimilars and that is 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.
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