With Zarxio’s entry into the U.S. market still pending, pharmacists need to be aware of biosimilars in order to better assist their patients.
While the U.S.’s first approved biosimilar, Zarxio is yet to be available to prescribers and patients amid ongoing legal battles, the fact is that biosimilars will soon be a reality on the U.S. market. Patients will want access to proven treatments at lower costs, while policymakers will want to reduce healthcare expenditures. All the while, healthcare providers and patient advocates want to ensuring that the rush to make biosimilars available doesn’t neglect safety concerns.
The FDA has yet to release its final stance on biosimilar naming conventions, and it has not yet established criteria for biosimilar interchangeability either. Still, Dr. Lucio seems in favour of making drug substitution easy for pharmacists, saying that in Europe biosimilars have worked “as expected” with similar safety and efficacy profiles to brand name drugs.
When the FDA does establish its biosimilar interchangeability criteria, each state will still need to determine its own substitution permissions. Most states do not have substitution laws in place for biosimilars, and according to Dr. Schondelmeyer, those that do include language to make substitution difficult.