Jonathan Kay, MD

Disclosures

December 09, 2015

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Hello. I am Dr Jonathan Kay, professor of medicine and director of clinical research in the division of rheumatology at the University of Massachusetts Medical School and U Mass Memorial Medical Center, in Worcester.

I am reporting from San Francisco, where I have been attending the 2015 American College of Rheumatology annual scientific meeting. There have been a number of major therapeutic advances discussed here, especially data about small molecules' novel mechanisms of action in inflammatory arthritis, and other topics completely unrelated to inflammatory arthritis.

There has been a lot of buzz about biosimilars, a therapeutic area that I have been very interested in and involved in myself. At this meeting, there have been a number of presentations of phase 3 studies of biosimilar agents—copies of adalimumab, etanercept, and infliximab—that are getting ready for marketing approval by regulatory agencies.

Dr Stanley Cohen presented Amgen's data from ABP 501, an adalimumab biosimilar,[1] which was, fortunately, a very "boring" presentation because the molecule was biosimilar—tracked very similarly in terms of efficacy over time, immunogenicity, and safety—and showed itself to be a biosimilar adalimumab in patients with rheumatoid arthritis inadequately responsive to methotrexate.

Professor Josef Smolen presented another "boring" presentation (which is good for biosimilars) titled, Samsung Bioepis’s SB2 Biosimilar Infliximab[2], which can be described exactly the same way as Dr Cohen's presentation, in terms of showing the same efficacy and safety as the originator molecule.

Another presentation was by Professor Paul Emery,[3] which also was rather "unexciting"—and desirably so—in terms of efficacy and safety about a biosimilar etanercept made by Samsung Bioepis. But the interesting aspect of this presentation was that there was much lower immunogenicity of the biosimilar etanercept as compared with the referenced product, Enbrel®.

Now this is acceptable to regulators because as long as a biosimilar is similar in terms of efficacy and safety, it can be less immunogenic, as long as there is no difference in efficacy or safety in the patients who lack antidrug antibodies. In this study, there were significantly more patients who developed injection site reactions with the referenced product, Enbrel, than with the biosimilar.

But this conference presented three biosimilar molecules, one to adalimumab, one to etanercept, and one to infliximab, back to back, with very a similar trial design of looking at early time points—which are very sensitive parts of the study—to assess biosimilarity. The [collective] results showed successful demonstration of biosimilarity across three different agents in patients with rheumatoid arthritis inadequately responsive to methotrexate.

Together, the conference presentations introduced the rheumatology community to a group of therapies that will potentially provide our patients with very effective therapy at a lower cost. The world of biosimilars has now come to us, and I look forward to seeing many advances in this area over the next several months, if not the years to come.

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