By Anna La Noce, MD, PhD
In January 2017, the FDA released the draft guidance for interchangeability, entitled “Considerations in Demonstrating Interchangeability with a Reference Product.”Since then, a number of comments from different organizations were provided to the FDA. Among those, the Biosimilar Medicine Group, a sector group of Medicines for Europe, commented that, “The draft guideline emphasizes the theoretical risks associated with biosimilar medicines’ development and approval, without balancing those with the wealth of evidence gathered over the last decade in the EU where biosimilar medicines have been used in the clinical practice,” and also, “EU regulators have recently concluded that, on the basis of current knowledge, it is unlikely and very difficult to substantiate that two products, comparable on a population level, would have different safety or efficacy in individual patients upon a switch.”[1]
In line with the above comments, a considerable amount of reports of Real-World Experience or post-marketing studies of biosimilars in Europe have been presented at the recent EULAR conference (Madrid, June 14-17, 2017), and many symposia and sessions have been dedicated to the hot topic of switching by either originators’ or biosimilars’ developers.
A massive non-medical switch to biosimilars has occurred in European Nordic countries that are, therefore, providing robust follow-up data, but post-marketing or registry studies are also being conducted in other EU countries. A summary of the most relevant reports is below, and all abstracts can be found in Annals of Rheumatic Diseases, June 2017, vol. 76, suppl. 2.
Several presentations dealt with additional outcome data from the Nor-Switch study or observational studies of the infliximab biosimilar that was the first anti-TNF biosimilar compound launched on the market in Europe. Overall, the studies tended to agree that switching from the originator to the infliximab biosimilar did not lead to any particular safety concerns or loss of efficacy. Interestingly, in Denmark, more than 800 patients who switched to the biosimilar infliximab did not show any increase in the requirement of health services, thus meaning that an increase in healthcare cost would not be expected due to the switch. [2]
Besides new real world infliximab biosimilar data, this year at the EULAR, there were also several presentations on the more recently approved etanercept biosimilar, Benepali®. Prescription data from biologics registries showed a rapid and impressive uptake of Benepali® that was launched in the course of 2016.
Aggregated data from biologic registries of ankylosing spondylitis patients from five Nordic countries (Norway, Sweden, Denmark, Finland, and Iceland) showed that, for the first time, the number of patients prescribed a biosimilar exceeded those prescribed an originator, primarily due to prescription of the etanercept biosimilar.
A similar trend of a quick increase in etanercept biosimilar prescriptions for rheumatic diseases was observed in Germany, with a non-medical switch from the originator accounting for 44 percent of prescriptions. In Denmark, more than 1,500 patients with rheumatic diseases were switched from originator to biosimilar etanercept in 2016. A three-month follow-up after the switch showed that disease activity was largely unaffected. However, about nine percent of patients stopped treatment during a five-month follow-up period, with high disease scores and lack of methotrexate use being associated with discontinuation. A similar finding has been reported from Sweden, where nearly 2,500 rheumatology patients initiated treatment with the etanercept biosimilar in 2016, with 48 percent of those being a non-medical switch from the originator. After an average time of 43 days, seven percent of those patients were switched back to the originator and six percent of those who received adalimumab prior to the switch were switched back to adalimumab. [3] The reasons for switching back were not clear.
There were also reports on the importance of the communication strategy to explain to patients the reasons and benefits of the switch, as well as its importance for adherence to therapy and persistence.
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[1] http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/general/general_content_001832.jsp
[2] http://www.sciencedirect.com/science/article/pii/S104510561630001X
[3] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4893105/
About the Author
La Noce, MD, PhD, serves as Executive Medical Director, Clinical Development, Immunology & Inflammation at Syneos Health™. She is a physician who has dedicated the last 10 years to providing support on planning and executing clinical trials in various rheumatology indications, with a focus most recently on biosimilars. Her professional experience includes more than 25 years in the pharmacology industry, specializing in the clinical development of a variety of drugs in several therapeutic indications.
