If you’re taking a treatment for IBD, you’ve likely come across the term “biologics” or “biologic agent”. Biologic therapies, sometimes called monoclonal antibody biologic therapies, have been the most effective and established IBD treatment for nearly two decades, and includes familiar names like Humira and Remicade. However, in recent years, pharmaceutical companies have begun focusing on developing a slightly different type of drug called a “biosimilar”. Biosimilars are chemically similar to biologics, but because of how they are made, they are subject to different regulations that could make them a promising alternative to biologic agents.
Biologics vs. Biosimilars
In a 2016 survey by the European Federation of Crohn’s and Ulcerative Colitis Associations, 38% of the respondents with IBD answered that they were familiar with biosimilars.
What do you know about biologics and biosimilars? If you’re scratching your head, here you’ll find a summary of biologics and biosimilars, with an explanation of the differences, similarities, and benefits that matter to you as you consider your IBD treatment options.
What are Biologics?
Technical definition: A biologic is a medicinal product derived from a natural source and includes large, protein-based agents. These are typically obtained from living cell lines using recombinant DNA technology (ex: hormones and monoclonal antibodies).
Examples of IBD biologics: infliximab (Remicade, Janssen) natalizumab (Tysabri, Biogen), vedolizumab (Entyvio, Takeda), ustekinumab (Stelara, Janssen) certolizumab pegol (Cimzia), adalimumab (Humira)
What are Biosimilars?
Technical definition: A biosimilar is a biologic product that is highly similar the originator biologic agent in terms of characteristics, biologic activity, immunogenicity, efficacy, and safety. Biosimilars are reverse-engineered based on the originator product (biologic agents). The main developmental stage involves an analysis of its structure and function relative to the originator (biologic).
Examples of IBD biosimilars: biosimilar to infliximab marketed as Remsima [Celltrion Healthcare] in Europe and as Inflectra [Celltrion Healthcare] in the United States.
What is the difference between biologics and biosimilars?
Biologic therapies have been the most effective agents for treating IBD since the first biologic (Remicade) was approved for Crohn’s treatment in 1998. Originally considered a “last resort”, over the years, biologics are now considered a long-term therapy unless there is either loss of response or negative side effects. Biologic agents are known to be expensive.
Now, several of these biologic agents have either come off patent or are approaching patent expiration, pushing pharmaceutical companies to innovate: enter biosimilars.
While biosimilars are structurally similar to biologics, the development and regulatory process for biosimilars is different. Instead of independently establishing safety, immunogenicity, or efficacy, biosimilar development mainly focuses on proving (through randomized, controlled trials among the patient population) a lack of clinically meaningful difference between the biosimilar and the related biologic. This process uses extrapolation to infer that, if a new product proves biosimilarity to an existing product, then it will possess a similar safety and efficacy profile.
Advantages and disadvantages of biosimilars
The emergence of biosimilars poses both challenges and opportunities for IBD patients. Read on to learn about a few key pros and cons of biosimilars.
This is considered the main advantage of biosimilars, with the prediction that high competition will result in lower costs. While still rigorous, it appears that the regulatory process and costs for bringing a biosimilar to market are minimized when compared to biologics.
It’s been proposed that high competition and minimized regulatory costs will lead to increased accessibility and availability of biosimilar therapies—perhaps on shorter timelines, too.
Not enough data (yet)
Because biosimilars are still emerging, researchers are still gathering evidence for how (and how well) they work. In the absence of sufficient clinical data, questions have arisen surrounding the regulatory process, whether and how to establish true bioequivalence in biosimilars, and the lack of research on the potential risks for patients who switch from biologics to biosimilars. Researchers have pointed out the need for studies that will more clearly define the safety, efficacy, and immunogenicity of biosimilars in patients who are currently using biosimilar IBD therapies.
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Paramsothy, S., Cleveland, N. K., Zmeter, N., & Rubin, D. T. (2016). The Role of Biosimilars in Inflammatory Bowel Disease. Gastroenterology & Hepatology,12(12), 741–751. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5193082/
Peyrin-Biroulet L, Lönnfors S, Roblin X, Danese S, Avedano L. Patient perspectives on biosimilars: a survey by the European Federation of Crohn’s and Ulcerative Colitis Associations [published online July 31, 2016] J Crohns Colitis. doi:10.1093/ecco-jcc/jjw138.