Study Bodes Well for Biosimilars

Biosimilar TNF inhibitors are interchangeable with original versions, authors find

Researchers at Johns Hopkins University and Brigham and Women’s Hospital have found comparable efficacy and safety among biosimilar tumor necrosis factor (TNF)-alpha inhibitors, according to a report from Kaiser Health News. TNF inhibitors are commonly used to treat inflammation in patients with rheumatoid arthritis or inflammatory bowel disease.

The researchers reviewed 19 studies to determine how these biosimilars compared with their brand-name counterparts, focusing on efficacy and safety. They found that the biosimilars were “interchangeable” with the original versions, such as infliximab (Remicade, Janssen Biotech) and adalimumab (Humira, AbbVie). Their findings were published online in the Annals of Internal Medicine.

Co-author G. Caleb Alexander, MD, and his team studied overall patient outcomes, adverse events, and whether patients had immune-system reactions to the drugs. Approximately 1,400 subjects took part in the clinical trials, and more than 500 were included in observational studies that made up the meta-analysis. They concluded that preliminary evidence supports the biosimilarity and interchangeability of biosimilar and reference TNF-alpha inhibitors.

Study limitations included possible publication bias, the small sample sizes of many studies, and the lack of published studies for several biosimilars.

Since their arrival on the market, biologics have been major moneymakers for drug companies, according to the Kaiser report. AbbVie, for example, saw its quarterly net revenue jump by 18% in earnings reported last week, thanks to its biosimilar adalimumab.

The FDA approved its first biosimilar, Zarxio (filgrastim-sndz, Sandoz), which is used to treat chemotherapy-associated infections, in September 2015. And in April, the FDA gave the green light to a Remicade biosimilar, Inflectra (infliximab-dyyb, Celltrion/Hospira).

Inflectra has not yet launched in the United States, but in Europe, where it was approved in 2013, it reportedly costs approximately 30% less than the original drug. Zarxio was approximately 15% cheaper than its precursor, Neupogen (Amgen), when it launched in Europe in 2009.

Source: Kaiser Health News; August 2, 2106; and Annals of Internal Medicine; August 2, 2016.