What are Biosimilars?

Biosimilars

Biosimilars are medications that are a type of biologic therapy. Biosimilars are named for the fact that they are highly similar to an already approved biological product. Like biologics, biosimilars have bioengineered proteins that mimic certain functions in human genes or cells, and they 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 rheumatoid arthritis (RA) to reduce or better regulate the inflammatory response, which is overactive in conditions like RA.1-3

Biosimilars are not generics, although they are generally cheaper than the medicine they are similar to, called a reference medicine. Generics are characterized as having the same chemical structure and being exact copies of a reference medicine, and biosimilars aren’t exactly like their reference biologics. Biosimilars must undergo rigorous testing in large clinical trials before they receive approval from the U.S. Food and Drug Administration (FDA).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

Biosimilars for RA

Biosimilars that may be used in the treatment of RA include:

  • Amjevita™ (adalimumuab-atto)
  • Cyltezo® (adalimumab-adbm)
  • Erelzi™ (etanercept-szzs)
  • Ixifi™ (infliximab-qbtx)
  • Renflexis™ (infliximab-abda)

What is Amjevita?

Amjevita is a biosimilar to Humira® (adalimumab), and like Humira, Amjevita is a tumor necrosis factor (TNF) inhibitor. Amjevita can help reduce the symptoms of moderate to severe RA and stop or prevent the progression of the disease which can cause joint damage. Common side effects experienced with Amjevita include upper respiratory and sinus infections, headache, rash, and redness or pain around the injection site. Some side effects with Amjevita can be serious, including serious infections like tuberculosis (TB) or a reactivation of hepatitis B. Amjevita may increase the risk of developing certain cancers, such as lymphoma.4

What is Cyltezo?

Cyltezo is another biosimilar to Humira. Cyltezo can help reduce the signs and symptoms of RA and improve physical functioning in people with moderate to severe RA. As a biologic therapy, it can also stop or prevent the progression of the disease which can cause joint damage. Common side effects experienced with Cyltezo include include upper respiratory and sinus infections, headache, rash, and redness or pain around the injection site. Cyltezo may cause serious side effects, including life-threatening infections or increasing the risk of developing certain cancers, such as lymphoma.5

Cyltezo is not commercially available in the US at this time.

What is Erelzi?

Erelzi is a biosimilar to Enbrel® (etanercept) and is a TNF inhibitor. Common side effects include irritation at the injection site and an increased risk of injections. More serious side effects include life-threatening infections, such as TB, bacterial sepsis, fungal infections, or a reactivation of hepatitis B. Erelzi may increase the risk of developing certain cancers like lymphoma.6

What is Inflectra?

Inflectra is a biosimilar to Remicade® (infliximab) and may reduce the symptoms of moderate to severe RA and improve physical function, as well as stopping or preventing long-term joint damage due to chronic inflammation. Common side effects with Inflectra include upper respiratory or sinus infections, headache, abdominal pain, and reactions at the site of the injection. Some side effects may be serious, such as life-threatening infections. Inflectra may increase the risk of developing cancers like lymphoma.7

What is Ixifi?

Ixifi is another biosimilar to Remicade that may help reduce the symptoms of moderate to severe RA and stop or prevent long-term joint damage from RA. Common side effects with Ixifi include headache, upper respiratory or sinus infections, abdominal pain, and reactions at the site of the injection. Some side effects may be serious, such as life-threatening infections. Ixifi may increase the risk of developing cancers like lymphoma.8

Ixifi is not commercially available in the US at this time.

What is Renflexis?

Renflexis is also a biosimilar to Remicade and TNF inhibitor that may help people with moderate to severe RA by reducing their symptoms, increasing their physical function, and stopping or preventing long-term joint damage. Common side effects with Renflexis include abdominal pain, headache, upper respiratory or sinus infections, and reactions at the site of the injection. Some side effects may be serious, such as life-threatening infections. Renflexis may increase the risk of developing lymphoma or other cancers.9

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