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Considerable confusion surrounds the new world of biosimilar drugs. Here are the top five issues connected with biosimilars that pharmacists should know about.
Considerable confusion surrounds the new world of biosimilar drugs. Erika Lietzan, JD, associate professor at the University of Missouri School of Law, provided some legal guidance for pharmacists and physicians during a recent Wolters Kluwer Clinical Drug Information webinar.
Here are the top five issues connected with biosimilars that pharmacists should know about.
Biosimilars will most likely be branded, and physicians will be prescribing by brand name. These branded products are not substitutable, according to Lietzan. As a result, pharmacists will be dispensing the product as prescribed. “I don’t perceive any particular challenges for pharmacists dispensing these products; the prescriber will write a script, and the pharmacist will dispense what was written,” Lietzan said.
Insurers may require that the biosimilar – rather than the reference product – be dispensed, as biosimilars will likely cost approximately 15% to 20% less than the reference product. “A physician might write a script for the reference product, and the pharmacist might discover that the insurance covers only the biosimilar, so that may entail some back-and-forth [with the physician],” Lietzan said.
FDA has proposed that the names of all biosimilar agents contain four-letter suffixes to ensure that the branded drug can be distinguished from the biosimilar version in instances of manufacturing changes or adverse events.
“To ensure continued safety of a biological product, appropriate pharmacovigilance necessitates that FDA have the ability to track adverse events to a specific manufacturer (and as appropriate, site or lot for a particular biological product) and that surveillance systems be able to detect safety signals throughout the lifecycle of a product so that the Agency and the manufacturer can act swiftly and in a targeted manner to identify and address a problem,” the FDA wrote in its draft guidance.
However, FDA has encountered many objections to this proposal. The Federal Trade Commission (FTC), for example, said in late October that the FDA draft guidance on biosimilar naming may hinder competition, and FTC recommended that the agency consider alternatives.
Pharmacists may need to provide adverse event information connected with biosimilars to physicians, who will submit reports to the FDA, or they will submit the report themselves.
“One issue will be getting the adverse event reporting right [whether it’s the pharmacist or the physician reporting to FDA]. It is going to be really important to provide as much [information] as possible about the product the patient took and, especially, if the nonproprietary name is being used, to remember the suffix,” Lietzan said.
Because biosimilars – including Zarxio, the first FDA-approved biosimilar drug – are likely to be specialty drugs, they may be dispensed by specialty pharmacies.
“Maybe there will be some issues related to the use of specialty pharmacy down the road, but it’s hard to know what they will be,” Lietzan said. “A lot of products are physician-administered, so the issue isn’t specialty pharmacy vs. ordinary pharmacy; it’s dispensing by a specialty pharmacy vs. patients obtaining it from the hospital pharmacy.”