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BPCIA Transition Can't Fix Insulin Market Alone


A commentary in The Lancet suggests that the new biological pathway for insulin product approval, established in March, will be insufficient to address issues insulin prices and biosimilar uptake.

Although the lack of a competitive insulin marketplace is a concern, and a quarter of patients have had difficulty paying for their medication, the abbreviated new pathway for follow-on biologics will “not be sufficient in itself to address the insulin pricing problem,” according to a commentary in The Lancet.

The authors contend many hurdles still must be addressed, such as barriers to interchangeability and substitution of insulin products, insufficient education on the safety and efficacy of biosimilars, and anticompetitive practices by reference drug manufacturers.

On March 23, an abbreviated approval pathway under the Biologics Price Competition and Innovation Act (BPCIA) was implemented for follow-on biologic products, including insulin. The authors described this as “a major step” toward the development of a more competitive insulin marketplace with more affordable prices.

“The availability of biosimilar insulin and designation of an interchangeable insulin will be crucially important for reducing insulin costs and improving affordability, converting the insulin market into something more similar to that for bioequivalent generic drugs,” the authors wrote.

The Old Pathway Didn’t Work

Under the former pathway, which put competitor insulin products in the generic category, approval of these agents was difficult. The authors noted that no insulin products were approved in this way.

They added that the new pathway under the BPCIA would allow for new insulin products to achieve an interchangeability designation, allowing the switch from dominant brands to biosimilar insulins in the pharmacy without physician notification. “The availability of biosimilar insulin and designation of an interchangeable insulin will be crucially important for reducing insulin costs and improving affordability,” the authors wrote.

However, they noted that guidance for interchangeability was not finalized by the FDA until May 2019, and this was updated in November 2019. This late guidance may be responsible for the limited pipeline of new insulin products, the authors wrote.

“Our review of the commercial databases Pharmaprojects and AdisInsight found only 2 biosimilar products in clinical testing as of December 1, 2019,” they wrote. They also noted that multiple insulin products would probably be needed to bring down the average cost of medicine. “Moving from a monopoly to a duopoly does not consistently or substantially reduce prices for any drug,” they said, calling for legal reforms that facilitate, rather than hinder, substitution of biosimilar insulins.

Physicians and Patients Need to Know More

The authors warned that lack of knowledge of biosimilars among physicians and patients may also hinder uptake. Some physicians may be uncertain about biosimilars, patients and physicians may have brand preferences, and reference drug manufacturers may deliberately cast doubt on the quality and efficacy of biosimilars to preserve market share.

Physicians and patients need to have access to unbiased education materials in order to instill confidence in biosimilar insulins, said lead author Jing Luo, MD, MPH, in an interview with The Center for Biosimilars®. Luo, an assistant professor at the University of Pittsburgh in Pennsylvania, named the FDA as the least biased source of biosimilar education.

“I've heard that there are plans to expand the educational materials to educate doctors and patients about the safety and efficacy of biosimilar medicines. Hopefully, they will have additional materials in a more targeted effort in advance of the first biosimilar insulin,” he said.

Product hopping by dominant manufacturers, or the development of insulins with fresh exclusivity rights, remains a threat to the development of a healthy marketplace for insulin.

“Sanofi and Novo Nordisk have already introduced several follow-on products (eg, glargine U300, a more concentrated version of glargine U100; and degludec, an ultra-long lasting insulin) as a way to preserve market share in the face of imminent biosimilar competition for glargine U100 (Lantus and Lantus SoloStar),” they wrote.

The Labyrinthine World of Payer Contracts

A complex payer system for reimbursement of insulin costs poses yet another hurdle to market development. “Preexisting contracts and other incentives embedded in negotiations among these individuals will probably continue to support high list prices for insulin in the United States,” the commentary said.

Luo sees fixing the issues in the biosimilar insulin market as a gateway to fixing similar problems for the broader class of biological medicines. “For me, it's like a steppingstone. If we can figure out this particular space really well through either policy changes or regulatory changes, then hopefully we might learn something as we tackle the bigger pie, which is how do we deal with the problems of unaffordable biologic medicines,” he said.

Despite what stands in the way of the future of biosimilar insulin, Luo feels that the FDA is taking significant action to help the cause.

“Part of why I think the FDA’s efforts should be appreciated is the fact that they did finalize some of the guidance with respect to these issues. They're trying to be flexible, but I think, on the other hand, they're somewhat constrained because of congressional language and the wording of the BPCIA."

The FDA alone cannot fix all of these problems, and policy-makers will need to push legislation that promotes biosimilar uptake and take action against state ant-substitution laws that will limit accessibility to biosimilars.

“Through educational outreach and other changes, policy-makers will need to support the physicians’ choice to prescribe biosimilar insulin products and the patients’ willingness to take them, similarly to what is done now with generic drugs,” the authors wrote.

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