What are Biosimilars?
Biosimilars are a type of biologic therapy that are highly similar to an already approved biological product. Biologics are therapies that have bioengineered proteins that mimic certain functions in human genes or cells. Biological products (including biosimilars) are made from living organisms.
The sources used to create biological products may be human, animal, bacteria, or yeast. Biologics may be used to treat autoimmune diseases like inflammatory bowel disease to reduce or better regulate the inflammatory response, which is overactive in psoriasis.1-3
Are biosimilars generic forms of biologic products?
Biosimilars are not generics. Unlike generics, which have the same chemical structure and are exact copies of a reference medicine, biosimilars aren’t exactly like their reference biologics.
Biosimilars are generally cheaper than their reference medicine, and they provide another treatment option for patients. Biosimilars must undergo rigorous testing in large clinical trials before they receive approval, and the U.S. Food and Drug Administration (FDA) only approves biosimilars that have the same mechanism of action, route of administration, dosage form, and strength as the reference product.1,2
How similar are biosimilars to their reference products?
Although not identical, biosimilars need to produce no clinically significant differences in terms of safety and efficacy when utilized by an individual. Biosimilars also need to have the same mechanism of action, route of administration, strength, and dosage form as their reference product, in addition to having no clinically significant differences in terms of purity and potency.
When a biosimilar meets all of these requirements and produces the same clinical result as its reference product in any given patient, it can be considered interchangeable, a step up in equivalency.1
What are the side effects with biosimilars?
Like all medications, biosimilars can cause unwanted side effects. While each medication is unique and has its own potential side effects, common side effects of biologics include an increased risk of infections (bacterial, viral, and fungal) and injection site reactions (redness, pain, and/or swelling of the area where the injection is given).
Sometimes, the infections people taking biologics develop can be serious or life-threatening, and some people experience severe allergic reactions to biologics. Rarely, less common side effects can occur with biologic medications like central nervous system disorders (vision problems, numbness, or tingling), cardiac issues (worsening or sudden onset of heart failure, which may appear as shortness of breath or sudden swelling of the hands or ankles), or Lupus-like syndrome (a rash that affects the face and arms and worsens in the sunlight, and joint or body pain).4
Biosimilars for inflammatory bowel disease
Though not all are available yet, there are several biosimilars that have been approved by the FDA for the treatment of IBD:
- Hyrimoz™ (adalimumab-adaz), a biosimilar to Humira®
- Cyltezo™ (adalimumab-adbm), another biosimilar to Humira®
- Amjevita™ (adalimumab-atto), another biosimilar to Humira®
- Hulio® (adalimumab-fkjp), another biosimilar to Humira®
- Inflectra® (infliximab-dyyb), a biosimilar to Remicade® (infliximab)
- Renflexis™ (infliximab-abda), another biosimilar to Remicade®
- Avsola™ (Infliximab-axxq), another biosimilar to Remicade®
- IXIFI™ (Infliximab-qbtx), another biosimilar to Remicade®