Jonathan Kay, MD


November 21, 2017

Hello. I am Dr Jonathan Kay, professor of medicine and the Timothy S. and Elaine L. Peterson Chair in Rheumatology at the University of Massachusetts Medical School and University of Massachusetts Memorial Medical Center, both in Worcester, Massachusetts. I am here in San Diego reporting for Medscape from the 2017 American College of Rheumatology Annual Scientific Meeting.

Research Updates on Biosimilars

There are a number of presentations about biosimilars at this meeting. Data will be presented about four different biosimilars at an oral abstract session:

  • Results from a 52-week comparative effectiveness study comparing GP2013, Sandoz's rituximab biosimilar, with reference rituximab will be presented.[1] The biosimilar was shown to be equivalent in efficacy and comparable in safety to the reference product.

  • Data will be presented on FKB327,[2] a biosimilar adalimumab manufactured by Fujifilm Kyowa Kirin Biologics in Japan. This 24-week, double-blind, comparative effectiveness study with an open-label extension demonstrated that the biosimilar adalimumab was equivalent in efficacy and comparable in safety to the reference adalimumab product.

  • GP2015 was approved in the United States as etanercept-szzs, a biosimilar manufactured by Sandoz that was studied only in psoriasis. The approval was based on the EGALITY study.[3] Data will be presented on 24-week results in rheumatoid arthritis from a study[4] that showed equivalent efficacy and comparable safety to reference etanercept.

  • Data will be presented on the 26-week open-label extension for the NOR-SWITCH study,[5] a randomized, blind comparative study looking at continued treatment with reference infliximab versus biosimilar CT-P13 infliximab (also known as infliximab-dyyb in the United States). This open-label extension was conducted at the end of the 52-week blinded period. Patients were either switched to the biosimilar or continued on the biosimilar. No differences in safety or efficacy were found in any of the indications by the end of the study.

'Great Debate' on Switching to Biosimilars

A great debate will take place tomorrow, when I will debate Roy Fleischmann on the question: to switch or not to switch? I will be taking the side in favor of switching to biosimilars, and Dr Fleischmann will be taking the easier side of arguing against switching, on the basis of an inadequate amount of data available to date. Certainly, the absence of evidence does not mean evidence of absence. I hope to prevail and indicate that there are potential benefits to biosimilars.

First and foremost, because biosimilars are equivalent in efficacy and comparable in safety to the reference products, the availability of biosimilars at a lower cost than the reference product should decrease the cost of treating patients. However, discounting and rebating of the reference product may actually lead to the reference product being lower in price than the biosimilar.

However, this lower price of the reference product has been provoked by the availability on the market of biosimilars, so the lower-priced biosimilar or the lower list-priced biosimilar introduces market competition that provokes these discounts and rebates for the originator and lowers the overall cost of treatment with that molecule. Multiple biosimilars of the same reference products are available, such as infliximab-dyyb (Inflectra®) and infliximab-abda (Renflexis™). Renflexis is discounted 35% compared with Inflectra, which is discounted 15%.

Regardless, the effect of this market competition should drive down the price of medications and should make treatment more readily available to patients for whom the originator molecule had originally been inaccessible. Greater global access to effective biopharmaceuticals should reduce disability, morbidity, and mortality associated with inflammatory diseases and should benefit patients worldwide.

At this 2017 Annual Scientific Meeting, new data will be presented about biosimilars, and Dr Fleischmann and I will be debating whether to switch or not to switch. There will be an additional session on Monday, in which I talk about interchangeability, and there will be a presentation about the regulations surrounding biosimilars.

Thank you for your attention, and I look forward to seeing you again on Medscape. I am Jonathan Kay.


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