New Humira Biosimilar, Abrilada, Receives FDA Approval

This week, the United States Food and Drug Administration (US FDA) approved Abrilada (adalimumab-afzb) as a biosimilar to Humira (adalimumab).

Abrilada is a biologic drug made by Pfizer, Inc. It is used for the treatment of adults with moderately to severely active rheumatoid arthritis. It is also indicated for use by children with moderate to severe juvenile idiopathic arthritis.

For those with RA, Abrilada may be taken on its own or in combination with methotrexate or another non-biologic DMARD (disease-modifying antirheumatic drug). Other uses of Abrilada include psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, and plaque psoriasis. Humira is used for these conditions as well.

What is a biosimilar?

Biologic medications are made using cells from living things. While this is incredibly helpful for creating powerful treatment options, it makes it difficult to recreate them. Unlike generic medications which can be exact copies of ingredients, biologic drugs cannot be exactly replicated.

Biosimilars are biologics recreated

When a pharmaceutical company is trying to recreate a biologic, they are creating a biosimilar, not a generic. This means the new medication is very similar, and acts essentially the same in the body, but is not exactly the same as the original. Biosimilars are important because they increase the number of potential treatments on the market for a particular condition, like RA. This can help reduce costs and increase potential drug options for those who need them.

Abrilada is a biosimilar for Humira

Abrilada was found to be a biosimilar to Humira after the FDA reviewed the results from the REFLECTIONS B538-02 research study. This trial included almost 600 adults with RA and compared the safety and efficacy of Abrilada and Humira. No clinically meaningful differences were found between the two drugs when taken alongside methotrexate. This means Abrilada was found to be a biosimilar to Humira and approved for many of the same conditions.

How does Abrilada work?

Both Abrilada and Humira are monoclonal antibodies that block TNF-a (tumor necrosis factor-alpha). Antibodies naturally occur in our body and play a role in our immune system. A genetically modified monoclonal antibody, like Abrilada or Humira, is designed to target a specific step in our immune response. These medicines block the action of TNF-a, which is thought to play a role in the inflammatory response.

Blocking TNF-a to help reduce joint-related inflammation and damage

TNF-a is a signaling factor called a cytokine that leads to more inflammation. For those with RA, this inflammation can be in the joints and lead to damage. Blocking TNF-a may help reduce joint-related inflammation and damage for those with RA and may lead to an improvement in symptoms.

Things to consider with Abrilada

Abrilada comes with similar warnings to Humira. Specifically, it has a warning that serious infections may occur when taking the drug. These include bacterial, viral, fungal, and other infections. People who have an active infection or who have had tuberculosis or hepatitis B in the past may not be able to take Abrilada.

Abrilada may also increase a person’s risk for cancer, including lymphoma or other malignancies. The most common side effects reported with Abrilada include headache, rash, injection site reactions, and infections including upper respiratory infections. A doctor can help determine if the benefits of taking Abrilada outweigh the risks.1

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This article represents the opinions, thoughts, and experiences of the author; none of this content has been paid for by any advertiser. The team does not recommend or endorse any products or treatments discussed herein. Learn more about how we maintain editorial integrity here.

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