A biosimilar is highly similar to, but not an exact copy of, a biologic reference product already approved by the FDA. Biologics and biosimilars can help patients with moderate to severe IBD.
Biosimilars are a class of medicines that are based on and may be used instead of biologics.
The market for biologics and biosimilars is expected to grow. This should benefit you and your health care provider by increasing treatment options and improving access to vital drugs at lower costs.
Biosimilars should not be confused with generic medicines (generics).
In order for a biosimilar to be approved by the FDA, it must meet strict standards to show that it works the same way as the reference product and produces no meaningful clinical differences in terms of safety and effectiveness from the reference product.
As biosimilars become more available, it is important for you and your health care provider to understand what they are and how they can be used to treat a wide range of diseases.
Health care providers need to know how to prescribe and administer these drugs to you and be ready to answer your questions about their safety, effectiveness, risks and side effects (unintended results of a medicine).
Biologic and biosimilar medicines can help patients with moderate to severe inflammatory bowel disease (IBD), who have not responded to, or who are not candidates for other treatments. Biologics are an important treatment option for IBD. They work by targeting specific proteins or cells in the immune system (the body’s natural defense against illness and germs) involved in the inflammatory process.
IBD most often refers to two conditions — ulcerative colitis and Crohn’s disease — which are characterized by inflammation (swelling) of different parts of the digestive tract. The exact cause of IBD is complex, but research shows it may be the result of someone’s immune system attacking healthy cells and tissue in the digestive tract by mistake.
Although IBD cannot be cured by biologics or biosimilars, both can help keep symptoms in remission (when symptoms are less or go away) and improve quality of life for many patients with moderate to severe IBD. They also have an advantage over other medicines used in IBD, because they are more targeted and selective in the body and in their medical effect.
Biologics for IBD work by targeting specific proteins or cells in the immune system involved in the inflammatory process. At this time, there are three types of biologics used to treat IBD. They include:
In 2016, the FDA approved the first two biosimilars to treat IBD. While biosimilars are not yet commonly used for treatment in IBD, it is important to know that they are now an option and to expect that the number of biosimilars available will soon increase. In certain circumstances, biologics and biosimilars may even be appropriate to prescribe along with other commonly used immunosuppressive IBD medicines. This is called combination therapy.
When considering biologics and biosimilars as a potential treatment, it is important for you and your health care provider to work closely together and discuss these medicines thoroughly. This will help ensure you have the information you need to take the medicine safely and effectively. Some key points to discuss include:
Biologics and biosimilars are medicines that need to be taken consistently and as directed by your health care provider.
You should feel encouraged to actively participate in discussions with your gastroenterologist and other health care providers. This will help you feel like your needs have been put first, which has been linked to staying on a treatment plan, better agreement to treatments and better clinical outcomes.
Both biologic reference products and biosimilars have unique and rigorous pathways for FDA approval. These usually involve additional quality assurance testing compared to chemically-formed drugs, as well as clinical and non-clinical data to ensure safety and effectiveness for patients.
It should also be explained to you that usage of these medicines is carefully watched when they enter the market. You can help improve the safety of these drugs by taking your medicine as directed and reporting any side effects or adverse reactions as soon as they occur.
Each insurance company covers biologics and biosimilars differently.
If your insurance company requires you to first try and see if another, cheaper biologic or biosimilar does not work for you before agreeing to cover the first therapy prescribed by your health care provider, work with your provider’s office to contact your state health department to file an appeal.