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 approach