James Stevenson, PharmD: Legal Battles, Payer Policies, Pharmacovigilance Pose Challenges for Biosimilars

Developments at the FDA and greater physician acceptance of biosimilars made 2017 a banner year for emerging therapies, according to James Stevenson, PharmD, FASHP, professor of clinical pharmacy at the University of Michigan College of Pharmacy.

In an interview with The Center for Biosimilars^®, Stevenson welcomed the FDA’s long-awaited draft guidance on demonstrating interchangeability of a biosimilar with its reference: “The industry’s really been waiting for that for a long time, so having that finally written down was, I think, a big step forward,” said Stevenson. “Understandably, [interchangeability is] still on a case-by-case basis with the manufacturer working with the FDA, but it at least provides a foundation for an interchangeability designation” in the future.

However, Stevenson added that the US emphasis on interchangeability may be somewhat misguided. “I think ultimately we’ll probably end up looking back and regretting that we had 2 designations, a biosimilar designation and an interchangeable biosimilar designation.” The true goal of treating a patient with a biosimilar is to produce the same clinical efficacy and safety as a reference product would, “and all biosimilars should be able to meet that,” said Stevenson, adding that a more appropriate focus might be conducting adequate studies and having detailed records of real-world use made available.

Greater physician acceptance of biosimilars over the past year was a welcome development for Stevenson, however. He sees the growing willingness to consider using biosimilars reflected by the fact that specialty physician organizations are beginning to issue new statements—or modify old ones—encouraging the use of biosimilars. “I think it’s primarily greater understanding of the regulatory process around biosimilars as well as greater experience with the products, particularly in Europe,” he said.

Yet 2017 also held notable disappointments: “Despite the fact that we continue to approve biosimilar drugs,” said Stevenson, “legal challenges continue to delay the introduction for many of these into practice. I was disappointed with the settlement that’s going to keep the adalimumab [Humira] biosimilar off the market until 2023. I hope we can do a better job.”

Additionally, “We’re starting to understand that payer policies are starting to have a substantial impact on the adoption of biosimilars,” said Stevenson, who is particularly concerned that some payers only authorize the use of specific biosimilars for given references (in the case of infliximab). Such a policy leads to practical problems for health systems, who may have to stock and manage 3 products in their facilities to accommodate all payer demands.

Looking ahead to 2018, “The biggest issues that I see that need to be addressed are related to legal challenges that are keeping biosimilars from reaching the marketplace,” said Stevenson, though he added that practical concerns, like pharmacovigilance, are also of interest. “It’s clear we don’t always do a great job correctly identifying the right product. My personal view is that [the situation is] going to be even worse with the naming convention that we have in the US unless all the healthcare providers really focus on the brand name.”