Postmarketing Surveillance Urged for Remicade Biosimilar

February 11, 2016

"I remain cautiously optimistic that competition will improve patient access, as I support formal postmarketing surveillance in the form of registries as I welcome CT-P13."

 Introduced in the late 1990s, biologic response modifiers (“biologics”) have drastically changed medical care in rheumatology. Administered parenterally, biologics target cytokines or their receptors, or interfere with binding to cell surface molecules. When added to a traditional oral disease-modifying anti-rheumatic drug (which can be insufficient in decreasing the inflammation of certain rheumatic diseases), biologics have increased the odds of remission, significant disease modification, and decreased cardiovascular events - but at a staggering five-figure annual cost that can limit patient access.

Available for several years in Europe, biosimilars offer comparable levels of quality, safety and efficacy. When I learned that biosimilars were coming to the U.S., I was excited. As I’ve learned more about the process and quality standards for manufacturing biosimilars, my hope for decreased costs were dampened. Biologics are made in living cell cultures, not chemistry laboratories. Thus, these drugs aren’t generic versions of a chemical compound, but complex proteins developed by a reverse engineering process.

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An FDA committee is reviewing CT-P13, a biosimilar of infliximab (Remicade) that is already available in Europe and elsewhere. CT-P13 has comparable long-term efficacy to infliximab in patients with ankylosing spondylitis who received either CT-P13 or Remicade (1). However, CT-P13 is safe and effective in inflammatory bowel disease, but patients previously treated with infliximab had decreased response rates and increased odds of developing allergic reactions (2). Thirty-nine patients with various rheumatic diseases agreed to switch from Remicade to CT-P13 (3). While clinical effectiveness was similar, 11 patients (28.2%) discontinued CT-P13 for various reasons.

Isaacs et al. reviewed concerns about biosimilars, such as immunogenicity and use of different doses in different diseases. They concluded that the effect should be positive because of likely price reductions and, in turn, increased patient access (4). They also recommended continued monitoring of the safety and efficacy of biosimilars in clinical practice through the use of registries. 

I remain cautiously optimistic that competition will improve patient access, as I support formal postmarketing surveillance in the form of registries as I welcome CT-P13.

 

Kristine Lohr, M.D., MS, is a member of the Rheumatology Network editorial board and a professor of medicine and director of the rheumatology fellowship program at the University of Kentucky in Lexington. Throughout her career, Dr. Lohr’s research has focused on undergraduate and graduate medical education, implementing curricula and overseeing outcome improvements. She has served on the standard setting panels for the National Board of Medical Examiners. In 2014 she became a member of the American Board of Internal Medicine Rheumatology Board. In 2015, she joined the U.S. Bone and Joint Initiative Board (representing the American College of Rheumatology). Recently, Dr. Lohr has researched the predictive value of in-training examinations in the American College of Rheumatology. Dr. Lohr specializes in autoimmune diseases, lupus, gout and rheumatoid arthritis. She received her doctor of medicine from the University of Rochester School of Medicine and Dentistry.

 

References:

 

Comparable long-term efficacy, as assessed by patient-reported outcomes, safety and pharmacokinetics, of CT-P13 and reference infliximab in patients with ankylosing spondylitis: 54-week results from the randomized, parallel-group PLANETAS study. Park W, Yoo DH, Jaworski J, Brzezicki J, Gnylorybov A, Kadinov V, Sariego IG, Abud-Mendoza C, Escalante WJ, Kang SW, Andersone D, Blanco F, Hong SS, Lee SH, Braun J.Arthritis Res Ther. 2016 Jan 20;18(1):25. doi: 10.1186/s13075-016-0930-4.

 

Efficacy and Safety of the Biosimilar Infliximab CT-P13 Treatment in Inflammatory Bowel Diseases: A Prospective, Multicentre, Nationwide Cohort. Gecse KB, Lovász BD, Farkas K, Banai J, Bene L, Gasztonyi B, Golovics PA, Kristóf T, Lakatos L, Csontos ÁA, Juhász M, Nagy F, Palatka K, Papp M, Patai Á, Lakner L, Salamon Á, Szamosi T, Szepes Z, Tóth GT, Vincze Á, Szalay B, Molnár T, Lakatos PL. J Crohns Colitis. 2016 Feb;10(2):133-40. doi: 10.1093/ecco-jcc/jjv220. Epub 2015 Dec 10.

 

Expert Opin Biol Ther. 2015 Dec;15(12):1677-83. doi: 10.1517/14712598.2015.1103733. Epub 2015 Nov 7.Clinical effectiveness of CT-P13 (Infliximab biosimilar) used as a switch from Remicade (infliximab) in patients with established rheumatic disease. Report of clinical experience based on prospective observational data. Nikiphorou E1, Kautiainen H2, Hannonen P1, Asikainen J1, Kokko A1, Rannio T1, Sokka T1,3.

 

J Intern Med. 2016 Jan;279(1):41-59. doi: 10.1111/joim.12432. Epub 2015 Sep 25. Biosimilars in immune-mediated inflammatory diseases: initial lessons from the first approved biosimilar anti-tumour necrosis factor monoclonal antibody. Isaacs JD1, Cutolo M2, Keystone EC3, Park W4, Braun J