Tony Hagen is senior managing editor for The Center for Biosimilars®.
The conference was designed to further collaborative efforts between the FDA and the Federal Trade Commission (FTC) and generate public confidence in regulators’ commitment toward fostering a healthy biosimilars marketplace, but the goal is not to put manufacturers of innovator biologics on edge, said Stephen M. Hahn, commissioner of the FDA.
At a workshop in Washington DC, members of the FDA and Federal Trade Commission described a difficult environment for biosimilar uptake that is rife with anticompetitive practices, from patent thickets to deliberate misinformation. These barriers must be overcome, they said, in order to develop a vibrant marketplace that leads to drug price reductions and benefits for patients.
In remarks that kicked off the daylong stakeholder conference attended by government and industry representatives, Stephen M. Hahn, commissioner of the FDA, stated that “shenanigans” must be ironed out of the biosimilars landscape, echoing language from Scott Gottlieb, former FDA commissioner and an acknowledged champion of biosimilar market development.
The conference was designed to further collaborative efforts between the FDA and FTC and generate public confidence in regulators’ commitment toward fostering a healthy biosimilars marketplace. But the goal is not to put manufacturers of innovator biologics on edge, Hahn said. “It’s not meant to be an us-versus-them situation.”
The workshop also featured extensive discussion about truth in advertising and product promotion. Methods of enforcement—mostly through the form of warning letters—were discussed, as were distinctions that govern the ways that manufacturers of reference products and biosimilars can describe their products in relation to others on the market. The issue, regulators said, is that the temptation to try to make biosimilars appear inferior to reference products is very strong and this does occur.
“We have serious concerns about false or misleading statements,” said Dominic Cirincione, regulatory counsel for the Office of Prescription Drug Promotion in the FDA’s Center for Drug Evaluation and Research (CDER).
A tutorial on what advertising can and cannot say was provided by Elizabeth Pepinsky, health science policy analyst for the Office of Prescription Drug Promotion at CDER. “To be approved for marketing, a biosimilar does not have to be identical to the reference product; however, promotional representations should avoid stating that a product is not similar because it is not identical,” she said.
Further, companies should avoid promotional representations that suggest there are clinically meaningful differences between a reference product and a biosimilar or that a biosimilar is not highly similar to its reference product, Pepinsky said.
Much of whether advertising is fair or not hinges on whether an impression is created that biosimilars are not quite safe or effective, noted Lowell Schiller, principal associate commissioner for policy at the FDA. “Brand manufacturers have obvious incentives to discourage competition, but it undermines our system,” he said.
Failure to mention product risk, making risk seem minimal, and overstating effectiveness of drugs, which includes making unsupported claims and misrepresenting data from clinical studies, are other common problems with promotional activity that regulators work to counteract, speakers at the workshop said. When making claims about clinical efficacy, the safest route is to stick with the data encompassed by the approved product label, they said.
Companies that have any doubts about the legality of their promotional materials for biosimilar and reference products are welcome to submit drafts of those to the FDA for review, Cirincione said.
The importance of having this discussion is evident in the numbers, noted Murray Aitken, executive director of the IQVIA Institute. Biologics now represent 42% of the total medicines market, up from 30% in 2014, he said.
Twenty-six biosimilars have been approved by the FDA so far, and the most recent to reach market was Pfizer’s trastuzumab biosimilar, Trazimera, launched on February 19, 2020, for a total of 15 launched and 11 still hovering between FDA approval and launch in the US market. “We have every reason to be optimistic” that the US biosimilar market will continue to develop with new drug entrants, said Christine Simmon, executive director of the Biosimilars Council. “But we must avoid cockeyed optimism,” she added.
She explained that there are multiple issues, including exclusionary contracting practices, rebate agreements, misinformation, and reimbursement and formulary placement policies that create an extended grey zone between FDA approval and product launch. Patent abuses rank high among these problems. Therefore, many potential marketers of biosimilars are taking a “wait and see” approach, she said.
The designation of interchangeability, which allows a pharmacist to give a patient a biosimilar instead of a prescribed reference product, could play an important role in expanding the market for biosimilars, said Molly Burich, director of public policy for Boehringer Ingelheim.
“The draw is the substitution that may occur at the pharmacy level. However, that won’t happen for drugs that are not issued at the pharmacy, and although several self-administered biosimilars have been approved, none have been launched, Burich noted. “We still have a ways to go before we get there.”
Surya Singh, president of Singh Healthcare Advisors, said much of the skepticism over biosimilars among providers has dissipated in recent years, with educational efforts and the growing understanding of how closely approved biosimilars match their reference products. The chief impediment is not lack of understanding among providers but the “economics” created by such factors as formulary listings, product availability, patents, and negotiated agreements within provider systems for the use of particular drugs.