Biosimilars took center stage this year as the focus of the “Great Debate” at the ACR/ARHP Annual Meeting in San Diego.
On November 5, in a well-attended session in the conference center’s largest meeting room, the “pro” argument on the usefulness of biosimilars was presented by Dr Jonathan Kay, Professor of Medicine at the University of Massachusetts.
The “con” argument, that the research surrounding biosimilars has not provided enough evidence that switching can be allowed confidently, was offered by Dr Roy Fleischmann, Clinical Professor at the University of Texas Southwestern Medical Center.
The FDA defines biosimilarity as “no clinically meaningful differences between the biologic product and the reference product in terms of the safety, purity, and potency of the product.”
The ACR Annual Meeting Program Committee chose the topic because of the large impact the emergence of biosimilars will have on rheumatologists and their patients.
Pro: Biosimilars Are Safe, Effective, and Cost-Effective
Dr Kay began by explaining that all biologics are subject to variability, including normal batch-to-batch variability, drift (unintended alterations in the manufacturing process drift), and evolution (deliberate process changes made by the manufacturer).
This variability means that commercial lots of bio-originators are not identical, as demonstrated by a slide showing slight differences in US- and EU-sourced batches of infliximab (Remicade). Dr Kay argued that an approved biosimilar is no different from the reference molecule than the reference molecule is from other batches of itself.
Approved biosimilars have been shown to be highly similar to their reference product in extensive comparative analytical studies, and the clinical efficacy and safety of the reference product have already been established through extensive data. Thus, Dr Kay argued there is no need to demonstrate efficacy of the biosimilar in all indications.
Dr Kay presented data from the NOR-SWITCH study, a 52-week randomized, double-blind, non-inferiority phase IV trial in which patients with 6 different diagnoses were randomly assigned to receive an originator or biosimilar medication. The results showed similar treatment emergent events and similar immunogenicity with and without switching, as well as comparable long-term safety and efficacy of the biosimilar after switching from the originator.
Overall, the NOR-SWITCH study showed no difference in disease activity measures except in the patient global assessment, which Dr Kay maintained could be explained by the “nocebo” effect. This refers to the misattribution of bodily symptoms to a drug in patients who expect to experience distressing adverse effects or who have experienced such adverse effects in the past. Dr Kay suggested the nocebo issue could be addressed through education, collaborative discussion, and encouragement of patients.
Jorgensen KK, Olsen IC, Goll GL, et al. “Switching from originator infliximab to biosimilar CT-P13 compared with maintained treatment with originator infliximab (NOR-SWITCH): a 52-week, randomised, double-blind, non-inferiority trial.” Lancet. 2017 Jun 10;389(10086):2304-2316. doi: 10.1016/S0140-6736(17)30068-5. Epub 2017 May 11.
Jackie Syrop. “Take the Generic Patients Are Told. Until They Are Not.” New York Times. August 6, 2017.