What are Biosimilars?

Biosimilars are a type of biologic therapy that 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 psoriatic arthritis (PsA) to reduce or better regulate the inflammatory response, which is overactive in conditions like PsA.1-3

While they are generally cheaper than their reference medicine, biosimilars are not generics. Generics have the same chemical structure and are 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, 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

Biosimilars used in the treatment of PsA include:

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 PsA 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 PsA and improve physical functioning in people with PsA. 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 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 increased risk of developing certain cancers, such as lymphoma.5

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 infections. 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 Hyrimoz?

Hyrimoz is a biosimilar for Humira® (adalimumab), it is manufactured by Sandoz, a division of Novartis Pharmaceuticals. The active ingredient in Hyrimoz is adalimumab, a monoclonal antibody that works as a tumor necrosis factor (TNF) inhibitor. TNF is a protein that is involved in the inflammatory response and can be overproduced in inflammatory conditions like psoriatic arthritis. Common side effects of Hyrimoz include infections (e.g. upper respiratory, sinusitis), injection site reactions, headache and rash. Hyrimoz may increase the risk of developing cancers like lymphoma.

What is Inflectra?

Inflectra is a biosimilar to Remicade® (infliximab) and may reduce the symptoms of PsA and improve physical function, as well as stopping or preventing long-term joint damage due to chronic inflammation. Common side effects of 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 PsA and stop or prevent long-term joint damage from PsA. 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

What is Renflexis?

Renflexis is also a biosimilar to Remicade and TNF inhibitor that may help people with PsA 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

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

Written by: Emily Downward | Last reviewed: April 2018.
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