MS Session at CONy 2019

One of the discussions at this year’s CONy is the safety of, and justification for, the use of biosimilars over brand-name drugs in Multiple Sclerosis (MS). This very topic had already been the source of debate at CONy 2015 in Budapest1 and this Friday afternoon in Madrid, it made a come-back in an interesting session hosted again by Dr. Ron Milo from the Barzilai Medical Center in Ashkelon, Israel.

The topic of biosimilars is timely in the field of MS with drug patents starting to expire and generics entering the market. Dr. Milo started the session by defining the terms “generic” and “biosimilar” as they apply to fully characterized small molecules (<5 kD) and partially characterized biologics (5–150 kD), respectively. While generic drugs only require demonstration of bioequivalence, biosimilars may need further pharmacodynamic (PD) and/or clinical studies to establish similarities to the brand-name biologic. In Dr. Milo’s opinion, the case of difficult-to-characterize non-biologic complex drugs (NBCDs), such as glatiramer acetate (GA) showcases the limitations of the 2 approaches described above. Using any other manufacturing process than that of the original NBCD will undoubtedly lead to a significantly different chemical entity. As a result, according to Dr. Milo, such a drug would have to meet its own complete and distinct regulatory approval requirements.

Dr. Ovidiu Bajeranu from the University of Medicine and Pharmacy “Carol Davila” in Bucharest, Romania, presented a case in favor of using biosimilars in MS for the high cost-savings that they could offer with similar clinical efficacy. He warned, however, that follow-on GA (Fo-GA) should not be considered interchangeable with GA. On the other side of the debate, Dr. Klaus Schmierer from the Queen Mary University of London, UK, agreed that although biosimilars may seem more cost-effective on the surface, the negotiating power of national healthcare systems and payers could drive down the price of the brand-name biologics significantly, thus eliminating this theoretical edge.

While the majority of the audience initially voted in favor of the switch from brand name to generic drugs in MS, at the end of the debate most attendees shared the more skeptical view expressed by Dr. Schmierer. We can expect this debate to be carried over into next year’s program.

On the topic of MS diagnosis and monitoring, the use of cerebrospinal fluid (CSF) examinations was also debated at CONy 2019. While they have been included in the 2017 Revised McDonald criteria for the diagnosis of MS in people with clinically isolated syndrome (CIS), the inconvenience, pain, costs, and risks associated with lumbar puncture (LP) favor a careful case-by-case examination of their potential benefit over systematic implementation. At the end of the debate hosted by Dr. Uros Rot from the Ljubljana University Medical Centre, Slovenia, the voting audience was evenly split in the view that CSF is still important in the diagnosis of MS. To put this result into perspective, a pre-debate survey showed that responders where unanimously in favor of the diagnostic relevance of CSF.

The case against CSF examinations was presented by Dr. Brian Weinshenker from the Mayo Clinic in Rochester, Minnesota. In his argument, Dr. Weinshenker emphasized the importance of not causing harm to the patients by conducting invasive tests when they have no predictive value. In the pro-CSF corner, Dr. Konrad Rojdak from the Medical University of Lublin, Poland, reminded the audience that MS is a complex disease requiring a complex diagnostic approach. In his expert opinion, CSF examinations remain an important component in the diagnosis of MS to avoid potentially serious consequences of misdiagnosis.

References

  1. CONy 2015 Program. Available at: http://www.comtecmed.com/cony/2015/program.aspx. Accessed on 8 April 2019.