The FDA is the only authority that can designate a biosimilar as interchangeable with its reference product, which requires that the product has similar clinical results for the same indication.
With an increase in approved biosimilars, there has been an ongoing debate about interchangeability in switching from a biosimilar to a reference product.
The FDA’s interchangeability designation has been met with speculations and concern regarding biosimilars from many stakeholders. The FDA is the only authority that can designate a biosimilar as interchangeable with its reference product, which requires that the biosimilar has similar clinical results for the same indication.1
“An interchangeable biosimilar is a biosimilar that may be substituted at the pharmacy for the reference product without the intervention of the prescribing health care providers,” Chelsee Jensen, PharmD, BCPS, senior pharmacy specialist and pharmaceutical formulary manager at Mayo Clinic, said in a session at the Academy of Managed Care Pharmacy Nexus 2023 conference.2
Jensen added that a good example of interchangeability is with the unbranded biologic compared to a branded biologic. An unbranded biologic is “considered by the FDA to be equivalent to its brand name biological product under the same biologics license application,” according to the session.
Jensen added that interchangeability would reduce the cost burden of many biologic medications, especially in the pharmacy benefit market. She also discussed skinny labeling, which is when drug manufacturers seek approval for some but not all approved indications of the branded reference product.2
In the session, Prerakkumar Parikh, PharmD, director of Specialty Clinical Solutions at Magellan Rx Management; Thomas Scott Raisor, PharmD, MPH, MBA, BCACP, chief of Pharmacy and Therapeutics Section at Defense Health Agency; and Annie Schuster, PharmD, FAMCP, senior director of Clinical Pharmacy Programs at Cigna Healthcare, also discussed interchangeability for biosimilars and the complexity behind the logistics and laws.2
Parikh said that the interchangeability regulations do vary by state, so it would be beneficial for pharmacists to familiarize themselves with the regulations for the state they practice in.2 Jensen added there is a need for further education for interchangeability for patients and physicians. She said that switching does not have anything to do with the safety or efficacy of the biosimilar.2
Schuster said that there needs to be better conversation between the prescriber and their patients, whether or not there are financial incentives. She added that the role of the pharmacy benefit manager should help to explain cost sharing. She said that as prescribers gain more comfort with biosimilars, they will be able to look at the cost and understand their portion of that cost, whether it is under Part B or Part D benefits, and be equally helpful.2
Parikh said that provider hesitancy needs to be addressed and the approval process of biosimilars needs to be better explained to demonstrate the safety and efficacy profiles of the drugs.2
Furthermore, there is currently an FDA drafted legislation that will remove the interchangeability language from products. The panelists shared their thoughts on the removal of that language, for which most of them would be happy to see the interchangeability language removed.
“Hopefully, we can see more traditional driver of generic by competitions to hit the lowest price that is still good for the company, good for the drug, and affordable,” Raisor said in the session.2