A new survey by the American Gastroenterological Association (AGA) found that the majority of gastroenterologists reported prescribing biologic medicines to their patients, but that would also consider prescribing biosimilars even with concerns about their safety and efficacy.
Biosimilars are similar to, but not exact copies, of innovator biologics such as those prescribed for inflammatory bowel disease (IBD). The first biosimilar product, Zarxio (filgrastim-sndz; Sandoz), was approved by the Food and Drug Administration (FDA) in March 2015. The survey of 180 AGA members assessed their prescribing practices and perspectives on the safety and efficacy standards of biosimilars as they are poised to enter the marketplace.
The results of the survey were as follows:
- 96% of respondents said that they prescribe biologic medicines to their patients
- 40% felt they were extremely or very familiar with biosimilars and 51% were somewhat or slightly familiar with biosimilars
- 72% reported that they would be likely to prescribe biosimilars if they became available in the U.S., with 49% “extremely” or “very” likely to prescribe
- 71% and 59% said they would be likely to prescribe an interchangeable and non-interchangeable biosimilar, respectively
- 67% favored a policy whereby the FDA would not allow indication extrapolation in the approval of biosimilars for inflammatory bowel diseases relative to a policy that allowed for indication extrapolation
- 80% said they were concerned with the level of clinical similarity in terms of effectiveness and safety to the reference biologic and the biosimilar efficacy and 78% were very concerned about biosimilar safety/immunogenicity
- 55% believed that pharmacy-level substitution of interchangeable biosimilars should only be allowed with prescriber notification and 35% believed that pharmacy-level substitution should never be allowed
Physicians and patient groups have called on the FDA to issue further rules and guidance documents concerning the implementation of biosimilars and the AGA advocates that biosimilar drug names be distinguishable non-proprietary names so that patients should not be forced to switch their biologic treatments without prior notification of their healthcare provider
For more information visit Gastro.org.