FDA approves biosimilar to Humira


FDA’s pace of biosimilar approvals is picking up, as it approved two major drugs for rheumatoid arthritis and other inflammatory diseases in the past month.

FDA’s pace of biosimilar approvals is picking up, as it recently approved 2 major drugs for rheumatoid arthritis (RA) and other inflammatory diseases.

On September 23, FDA approved adalimumab-atto (Amjevita, Amgen), a biosimilar to Humira (AbbVie), to treat RA, psoriatic arthritis, Crohn’s disease and other inflammatory conditions. Plus, FDA recently gave the green light to etanercept-szzs (Erelzi, Sandoz), a biosimilar to Amgen’s top-selling Enbrel, also for RA and other inflammatory conditions.

Related: FDA approves first biosimiar Zarxio

Both new biosimilars stand to save patients and the US healthcare system millions of dollars. AbbVie’s revenue from Humira was more than $14 billion in 2015, making it the top-selling drug in the US, according to 24/7 Wall St. Enbrel, meanwhile, netted sales of $5.1 million in the United States last year, according to Fortune.

“This [Amjevita] is the fourth FDA-approved biosimilar. The biosimilar pathway is still a new frontier and one that we expect will enhance access to treatment for patients with serious medical conditions,” said Janet Woodcock, MD, director of FDA’s Center for Drug Evaluation and Research, in a press statement.

FDA’s approval of Amjevita is based on review of evidence that included structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamics data, clinical immunogenicity data and other clinical safety and effectiveness data that demonstrates Amjevita is biosimilar to Humira.

Related: Adoption of fast-growing biosimilars segment essential

However, FDA stressed that it approved Amjevita as a biosimilar, not as an interchangeable drug.

The most serious known side effects with Amjevita are infections and malignancies and the most common expected adverse reactions are infections and injection-site reactions.

Like Humira, the labeling for Amjevita contains a Boxed Warning to alert healthcare professionals and patients about an increased risk of serious infections leading to hospitalization or death. The Boxed Warning also notes that lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with tumor necrosis factor blockers, including adalimumab products. 

Read more: Biosmilars’ naming proposal could cause “significant” changes

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