Enbrel Biosimilar Gets Green Light

FDA approves Eticovo (etanercept-ykro) to treat several types of arthritis

(RxWiki News) Enbrel's new biosimilar recently got the green light it needed to treat several inflammatory health conditions.

The US Food and Drug Administration (FDA) recently approved Eticovo (etanercept-ykro). The FDA approved this new biosimilar to treat multiple inflammatory conditions, which include the following:

  • Rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis in adults
  • Plaque psoriasis in children and adults
  • Polyarticular juvenile idiopathic arthritis (JIA) in children

This medication is available as an injection and is to be administered under the skin once a week for most indications. When treating plaque psoriasis, Eticovo is to be injected twice a week for three months and once a week thereafter.

According to the FDA, a biosimilar product is a biological product that is very similar to a biological product that has already been approved (referred to as a reference product).

In this case, the reference product is Amgen's Enbrel (etanercept). Eticovo also had to show that it did not have a clinically meaningful difference from Enbrel in terms of safety, purity or effectiveness.

Common side effects of Eticovo included infections and reactions at the injection site, such as redness, swelling, itching or pain.

This medication carries a boxed warning (the strongest type of warning) regarding an increased risk of infection with the use of this medication. This is a risk that comes along with all medications like Eticovo.

Eticovo is not for everyone. If you are being treated for an infection, think you have an infection, or have signs or symptoms of an infection (such as fever, sweats or chills, cough or flu-like symptoms), tell your health care provider. This medication can lower the ability of the immune system to fight infections.

Your doctor will test you for tuberculosis before prescribing this medication and throughout treatment.

Speak with your health care provider about any questions you have about this new approval.

Written by Anyssa Garza, PharmD, BCMAS