Biosimilars are set to reshape specialized managed care pharmacy. But litigation among sponsors of biosimilar and reference biologic products, stakeholders’ pushback against the FDA’s recently-announced biosimilars naming rules, and clinician knowledge gaps and concerns might all slow adoption of biosimilar therapeutics.
That’s according to two analysts at the AMCP Managed Care & Specialty Pharmacy Annual Meeting, in Denver. They spoke at the meeting’s March 30 session, “Keeping Up with Biosimilars: The Latest on Regulation, Utilization, Monitoring, and Pipeline.”
Clinician confidence in biosimilars’ safety “will be crucial” to their acceptance and uptake, noted C. Douglas Monroe, RPh, MS, a drug information consultant based in Mission Viejo, California.
There are “key knowledge gaps” in physicians’ understanding of the regulatory landscape for biosimilars, he cautioned.
Patent disputes and a range of policy issues also need to be resolved, including naming and labeling, interchangeability, and the emergence of state-level biosimilar legislation.
A key court fight between Amgen and Sandoz regarding the biosimilar version of filgrastim is heading to the U.S. Supreme Court, and the ruling “could have huge implications for biosimilars moving forward,” noted Jennifer M. Day, PharmD, pharmacist project manager at Kaiser Permanente’s Drug Information Service in Downey, California.
“So far, it’s keeping a lot of patent attorneys gainfully employed but it is also creating a lot of uncertainty about when these biosimilar products will get to market,” Day said.