The Coalition of State Rheumatology Organizations, the country’s authority on state rheumatology society activities, recently conducted a survey of registered rheumatologists. The survey results revealed that while most of them are eager for biosimilars to become available, they still believe the US Food and Drug Administration should implement regulatory measures to promote patient safety.
According to the Coalition’s President, Michael Schweitz, MD, FACR, MACR, “Rheumatologists nationwide welcome the development of biosimilars as an avenue for improving patient access to important biologic medications. However, we also want to ensure patient safety is at the forefront of the FDA’s approval process as biosimilars come to market. This survey affirms that further guidance from FDA on critical issues such as interchangeability and naming are needed before additional biosimilars are approved.”
The survey’s results reveal that over 82% of rheumatologists believe that before biosimilars are freely used in place of the original medications, more thorough studies should be conducted, and over 75% feel it is important that these biosimilars be named distinctly from the original. The survey also reported almost all of the respondents agreed that any differences between the biosimilar and its original drug should be fully disclosed on the label.
As a result of these findings, the Coalition urged the FDA to mandate distinct names for biosimilars, further and more rigorous clinical testing, and complete disclosure of drug information.
In an earlier report on biosimilars for rheumatoid arthritis, Biogen and Samsung Bioepis Co., Ltd. have three exciting new anti-tumor necrosis factor (anti-TNF) biosimilars under development to treat patients with rheumatoid arthritis. Representatives from the companies will present data at the European League Against Rheumatism Annual Congress (EULAR 2015), which is being held this year in Rome. Findings indicate that these three therapies are promising candidates for rheumatoid arthritis.