Another Biosimilar Gets a Green Light Leave a comment


(RxWiki News) The US Food and Drug Administration (FDA) has approved another biosimilar. This one is meant to treat multiple conditions that affect the immune system.

This new approval is Renflexis (infliximab-abda). It was approved for Crohn’s disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis. All of these conditions are a result of the immune system attacking healthy parts of the body.

A biosimilar is a biological product that is highly similar to a product that has already been approved, according to the FDA. The previously approved product is known as a reference product. In this case, the reference product is Remicade (infliximab).

Renflexis is available as an injection to be administered by a health care provider. 

Common side effects may include reactions related to infusion, headaches and stomach pain. Infliximab-abda carries a boxed warning noting a risk for serious infections, which includes a risk of tuberculosis (TB). Because of this risk, your health care provider will test you for TB before starting treatment. Another serious risk of this medication is the potential for lymphoma and other cancers, according to the FDA. 

Ask your health care provider any questions you may have about treating autoimmune disorders.  

Merck & Co. markets Renflexis.



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