FDA Approves Biosimilar


The FDA today announced the approval of the biosimilar product infliximab-abda.

Officials with the FDA have announced the approval of infliximab-abda (Renflexis, Samsung Bioepis), which is a biosimilar to infliximab (Remicade, Janssen).

The announcement was made by the FDA via Twitter earlier this afternoon.

Infliximab is used in the treatment of Crohn’s disease and ulcerative colitis in both children and adults who have not responded to other therapies, as well as various forms of arthritis, including rheumatoid and psoriatic, as well as ankylosing spondylitis, and plaque psoriasis.

The similarity between Renflexis and the reference product has been demonstrated for indications, dosing, and administration. While the inactive ingredients vary between the 2 drugs, there are no clinically meaningful differences in safety and efficacy. Common adverse events include upper respiratory infections, sinusitis, and pharyngitis, infusion-related reactions, headache, and abdominal pain, according to the FDA.

According to this recently-published column in Pharmacy Times, this approval follows in a line of biosimilar approvals in recent years.

"In March of 2015, Zarxio (filgrastim-sndz), a biosimilar for of Neupogen, was the first biosimilar approved. Zarxio was followed by Inflectra (infliximab-dyyb) in April 2016, Erelzi (etanercept-szzs) in August 2016, and Amjevita (adalimumab-atto) in September 2016," wrote contributor Joanna Lewis, PharmD. "Many patents for biological drugs are expiring in the next several years and there are currently more than 50 biosimilars in trials in the United States and Europe. A study estimated that biosimilars could save the United States $44 billion dollars on direct spending of biologics between 2014-2024."1Reference

1. Mulcahy A, Predmore Z, Mattke S. The cost savings potential of biosimilar drugs in the United States. https://www.rand.org/content/dam/rand/pubs/perspectives/PE100/PE127/RAND_PE127.pdf. Accessed Feb 16, 2017.

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