Possible Impact of Biosimilar Infliximab on U.S. Market in Prescriptions, Pricing

“A lot of things need to be answered in the future, but those can only be answered with time and more data.”

Kimberly J. Retzlaff is a freelance medical journalist based in Denver.

References

1. Kim SC, Choi NK, Lee J, et al. Brief report: Utilization of the first biosimilar infliximab since its approval in South Korea. Arthritis Rheumatol. 2016;68(5):1076–1079.
2. Information on biosimilars. U.S. Food and Drug Administration. 2016 May 10. http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars.
3. Smits LJ, Derikx LA, de Jong DJ, et al. Clinical outcomes following a switch from Remicade to the biosimilar CT-P13 in inflammatory bowel disease patients: A prospective observational cohort study. J Crohns Colitis. 2016 Apr 19. pii: jjw087. [Epub ahead of print].
4. Yoo DH, Racewicz A, Brzezicki J, et al. A phase III randomized study to evaluate the efficacy and safety of CT-P13 compared with reference infliximab in patients with active rheumatoid arthritis: 54-week results from the PLANETRA study. Arthritis Res Ther. 2016 Apr 2;18(1):82.
5. Park W, Yoo DH, Jaworski J, et al. 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. Arthritis Res Ther. 2016 Jan 20;18:25.
6. Rheumatology community responds to FDA guidance on biosimilars labeling [news release]. American College of Rheumatology. 2016 Apr 1. http://www.rheumatology.org/About-Us/Newsroom/Press-Releases/ID/735/Rheumatology-Community-Responds-to-FDA-Draft-Guidance-on-Biosimilars-Labeling.
7. FDA approves Inflectra, a biosimilar to Remicade [news release]. U.S. Food and Drug Administration. 2016 Apr 5. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm494227.htm.
8. Rheumatology community responds to FDA approval of Inflectra (infliximab-dyyb), a biosimilar to Remicade [news release]. American College of Rheumatology. 2016 Apr 6. http://www.rheumatology.org/About-Us/Newsroom/Press-Releases/ID/737/Rheumatology-Community-Responds-to-FDA-Approval-of-Inflectra-infliximab-dyyb-a-Biosimilar-to-Remicade.

Editor’s note: The ACR strongly believes that safe, effective treatments should be available to patients at the lowest possible cost. Decisions regarding the approval and use of biosimilars must be driven by sound science. Read the ACR’s position statement on biosimilars at http://www. rheumatology.org/Portals/0/ Files/Biosimilars-Position- Statement.pdf.