Biosimilar for Ankylosing Spondylitis

A new biosimilar drug called CT-P13 was recently approved by the European Medicines Agency to improve symptoms of ankylosing spondylitis (AS)— including disease activity, disability, and mobility— just as well as the drug it is based on, infliximab, also known as Remicade.

According to a new study presented at the European League Against Rheumatism Annual Congress, CT-P13 is the world’s first biosimilar monoclonal antibody to receive approval and provides a cheaper, more cost-effective option for patients with AS. Biosimilars are generic versions of biologic drugs.

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One of the challenges of getting biosimilars approved is demonstrating not only that they are equivalent to the drugs they are made to imitate, but also that they are as safe and effective as their reference products, said lead study author Won Park, Ph.D., in a press release.

“By demonstrating comparable efficacy and safety, the results of our clinical trials should give physicians confidence in using CT-P13 as an alternative treatment option in AS patients,” Park said. “This is good news for patients who may previously have had limited access to costly antibody biopharmaceuticals.”

AS is a type of arthritis that primarily affects the spine and can cause pain and stiffness due to joint swelling, according to the U.S. National Library of Medicine. This condition affects an estimated 1.4 million patients in Europe, according to a report by the University of Aberdeen, and prevalence ranges from 0.1 percent to 1.4 percent in the U.S., according to the Cleveland Clinic.

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Demonstrating Equivalence

Researchers demonstrated that CT-P13 and the original infliximab are equivalent using a randomized, double-blind, parallel group study of 250 AS patients.

The team’s goal was to compare “disease activity, disability, and mobility" between the two groups.

At week 54, disease activity had improved significantly from baseline in both groups, and this improvement was similar between the groups. Disability and mobility also improved in a similar fashion, according to the study authors.  

The use of biological drugs can cause a patient's body to produce ADAs (anti-drug antibodies), making the drugs less effective. As expected, ADA-positive patients responded less well to both CT-P13 and infliximab in the study.

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Getting FDA Approval for Biosimilars

As the demand for quality healthcare increases, so does the challenge of keeping healthcare costs low, according to a 2014 report on biologics and biosimilars by Amgen, a biotechnology company working to develop these drugs.

“Regulated introduction of biosimilars into the market has been forecasted to increase access to much needed biologic medicines and reduce costs,” the report stated. "The biologic medicines market is expected to grow to $190-200 billion by 2015, with biosimilars a small but growing proportion at $2-2.5 billion.”

While CT-P13 has been approved by European regulators, it has not yet been approved by the U.S. FDA. 

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In 2009, the World Health Organization (WHO) developed a set of standards to assure the safety and quality of biosimilars. And in 2010, President Obama signed the Patient Protection and Affordable Care Act, creating a pathway for biological products demonstrated to be “biosimilar” or “interchangeable,” as part of the Biologics Price Competition and Innovation Act.

Under this act, “a biological product may be demonstrated to be 'biosimilar' if data show that, among other things, the product is 'highly similar' to an already-approved biological product,” according to the U.S. Department of Health and Human Services.   

"What it takes in the U.S  to get a biosimilar approved is a biosimilar sponsor needs to submit the relevant data package and other relevant requirements per the pathway to get approval," said Carrie Deverell of Amgen corporate affairs in an interview with Healthline.

"We have six biosimilars in development here at Amgen in pivotal studies and we’re excited about the opportunities for patients," Deverell said.

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