Is a biosimilar as safe and effective as the reference compound?
Possible answer: The FDA has approved biosimilar drugs, and will likely approve more, because they are believed to be safe and effective. Research is ongoing. Dr. Field says, “I believe the rheumatology community is willing to consider biosimilars for their patients if studies substantiate the safety and efficacy profiles are very similar to the parent compound and [if the biosimilar] is the best treatment option for them and their lifestyle.”
Rheumatologists want to have confidence telling patients it is okay to take a biosimilar, but most are opposed to mandatory medication switching of stable patients by insurance companies or pharmacies, Dr. Huston says. This could become an issue if insurance companies advocate switching medications or if patients are looking to change from a biologic to a biosimilar due to cost.
“The switching studies of brand to biosimilar are ongoing to determine interchangeability. This is still unclear,” Dr. Field says.
What are the cost savings?
Possible answer: “The pathway to FDA approval is less costly [for biosimilars], and the end price should be significantly less. We are all eagerly waiting more information regarding exactly how much less costly these drugs will be,” Dr. Huston says. However, early indications show the drugs may be somewhat less expensive, but still hard for an individual to pay. “It seems to me the initial push toward biosimilars will be driven more by insurance companies rather than patient preference.”
[Editor’s note: Wholesaler shipment of Inflectra in the U.S. began on Nov. 21, 2016. It is priced at a 15% discount to the current wholesale cost of Remicade. See http://www.the-rheumatologist.org/article/pfizer-announces-medicare-reimbursement-inflectra-infliximab-dyyb-first-biosimilar-monoclonal-antibody-available-united-states.]
The Rheumatologist has published several articles about biosimilars. For more information, visit:
- http://www.the-rheumatologist.org/article/update-legislation-notification-rules-concerning-substitution-interchangeable-biologic-drugs
- http://www.the-rheumatologist.org/article/second-biosimilar-equivalent-adalimumab
- http://www.the-rheumatologist.org/article/adalimumab-atto-biosimilar-of-humira-receives-fda-approval
- http://www.the-rheumatologist.org/article/celltrion-accelerates-u-s-launch-infliximab-dyyb-remicade-biosimilar
- http://www.the-rheumatologist.org/article/potential-benefits-pitfalls-biosimilars-reviewed-eular-2016
- http://www.the-rheumatologist.org/article/patients-know-biosimilar-drugs
- http://www.the-rheumatologist.org/article/biosimilars-unanswered-questions
- http://www.the-rheumatologist.org/article/arthritis-patients-lack-knowledge-safe-use-biologics
