Most Rheumatologists Want FDA to Better Regulate Biosimilars

A new survey from the Coalition of State Rheumatology Organizations (CSRO) has found a majority of rheumatologists are concerned about the safety of biosimilars. The findings add another critical voice to the efforts to ensure that novel treatments are used effectively in the future, according to an ACR committee member.

More than 82% of rheumatologists surveyed believe the U.S. Food and Drug Administration (FDA) must set rigorous standards for switching between biosimilar drugs. More than 75% of rheumatologists believe the FDA should make sure biosimilars have a different non-proprietary name than the innovator biologic medicine. And nearly 96% of respondents said the FDA should require labeling to identify a medication as a biosimilar.¹

“Most of the rheumatologists that I know are cautiously optimistic about biosimilars, but really concerned about the safety and efficacy piece,” says Kwas Huston, MD, a member of the ACR’s  Committee on Rheumatologic Care. “The survey demonstrates that there is an overwhelming consensus that we must be vigilant and make sure these drugs are safe.”

In addition to the survey results, CSRO announced policy recommendations on the naming of biosimilars to ensure there’s no confusion with the innovator product and the prominent display on labels of any safety difference between the biologic and its biosimilar. These recommendations closely mirror suggestions the ACR has pushed for regarding safety.

In March, the FDA announced it had approved the first biosimilar drug: the cancer treatment Zarxio. The potential for biosimilars in treating rheumatic diseases is something the ACR supports, but “decisions regarding approval of biosimilars must be driven by sound science,” the ACR’s position paper reads.²

“We require the FDA to provide diligent guidance on how these drugs will be evaluated and approved,” Dr. Huston adds. “I hope the FDA takes that to heart. The only way for biosimilars to enter the market and bring down overall costs [of treatment] is to ensure confidence in the safety and efficacy of these medications.”

Richard Quinn is a freelance writer in New Jersey.

References

1. Coalition of State Rheumatology Organizations. News release: CSRO releases physician biosimilars survey results. 2015 July 1.
2. ACR Committee on Rheumatologic Care. American College of Rheumatology position statement: Biosimilars. February 2015.