What Are Biosimilars?
Biosimilars are changing the way doctors treat patients with chronic diseases. These new medications are bringing lower cost alternatives to expensive innovator biological drugs—similar to the way in which generic drugs provided lower cost alternatives to chemical compounds–and biosimilars are becoming more common in clinical trials.
Biosimilars have been approved as a new class of medication; that is, they are derived from complex proteins and are similar in structure and function already approved biologic-based therapies. They work with your body’s natural processes to fight disease and illness—for example, by stimulating the development of white blood cells that help your body fight infections or cancer cells, or by enhancing the production of red blood cells to combat various forms of anemia.
Biosimilar drugs have been developed to reduce costs and improve access for patients who need treatment for chronic conditions such as diabetes, rheumatoid arthritis and inflammatory bowel disease. They can also be used in oncology treatments to help fight cancers like leukemia and lymphoma, which can require multiple courses of treatment over several years. Currently, biosimilars can result in savings of up to 27% compared to their innovator biologic counterparts, and these savings are expected to increase as more competitive products enter the market.
Biosimilars vs Generics
Biosimilars are not generics.
Generic products are well-regulated and have been approved by the FDA for years, as exact copies of brand name drugs. They are bioequivalent to their original counterparts, meaning they provide the same amount of active ingredient in the same amount of time. Generics can be substituted for other generics and for their brand name counterparts without affecting safety or efficacy.
Of all prescriptions written in the US, 90% are for generic drugs, which also comprise nearly 100% of drugs designated as Essential or Critical by the World Health Organization (WHO), U.S. Food and Drug Administration (FDA), and Centers for Disease Control and Prevention (CDC). In the U.S., 33 biosimilars have been approved. The size and pipeline of the biosimilar market continues to show strong growth in the US and globally.
Clinical trials are the global gold standard for validation of safety and efficacy, and so it was only a matter of time before biosimilars commanded a large share of the clinical trial pipeline.
Similar to their European counterparts, US clinical studies have demonstrated that biosimilars are highly effective and safe therapeutic alternatives to their reference biologic drugs. In addition, the approval process for a biosimilar allows the drug, once approved, to be used across all indications for which the reference drug is approved, without requiring costly additional trials to obtain this broad approval. Over time, as more and more biosimilar drugs are approved through clinical studies conducted worldwide, the end result will be enormous cost savings for patients who lack insurance or whose insurance plans do not cover these expensive drugs. It may also make it possible for patients in less developed global regions to have access to costly biologics that were never before economically feasible.
Biosimilars present an opportunity for new players in the industry due to the large value opportunity associated with biosimilars. In the future, biosimilars will have the potential to increase in prevalence and make up a significant portion of essential and critical drugs.
The Novum Advantage
At Novum, we possess unique experience in conducting biosimilar clinical trials. Our leadership team has successfully conducted biosimilar studies throughout North America, Europe, and Asia.
Contact the Novum Team
Interested in learning more? Fill out the form below to get in touch with our experienced team.