New FDA Policy May Speed Biosimilar Insulins to US Market

A new US Food and Drug Administration (FDA) policy may help get novel biosimilar insulins to market more quickly, but it will be no guarantee that the products will be significantly less expensive than branded insulins, say analysts.

The FDA recently issued new draft guidance for insulin biosimilar manufacturers.

The recommendations "may result in a more efficient development program that could ultimately bring biosimilar or interchangeable insulin products to the market more quickly," said Brett P. Giroir, MD, acting FDA commissioner, in a statement by the agency.

"The availability of approved biosimilar and interchangeable insulin products is expected to increase access and reduce costs of insulin products," he added.

Meanwhile, the Republican leaders of the US House Energy and Commerce Committee have written to the nation's largest insurers to demand that they provide information on their involvement in the rising price of insulin.

The committee wrote to Anthem, Blue Cross Blue Shield, CVS Health, Cigna Corporation, Kaiser Permanente, and UnitedHealth Group seeking transparency on rebate programs with pharmacy benefit managers (PBMs); detailed information on how they design their benefit plans and formularies; how much enrollees in high-deductible plans pay out of pocket for insulin; and whether the insurers offer patient assistance programs to help defray the cost of insulin.

"Unfortunately, even though the average net price that manufacturers are receiving for many insulin products is decreasing and PBMs are working with health plans to help reduce the cost of insulin for health plans, many Americans are facing increased out-of-pocket costs for their insulin at the pharmacy counter," the members of Congress wrote.

"Floodgates Opening": Clearer Path to Market for Biosimilar Insulins

Analysts and one industry group applauded the FDA draft guidance, stating that it gives a much clearer picture of how products can be developed and approved.

The new guidance — which will be made final once the agency takes public comments into account — has been expected for some time. The FDA issued final guidance on interchangeability of biosimilars in May and held a public hearing specifically on interchangeability of insulin biosimilars not long after.

The Association for Accessible Medicines (AAM) said it was continuing to review the draft guidance but believes it reflects much of the concerns and feedback it gave the agency at the May hearing.

"We find FDA's flexibility on the implementation of statutory interchangeability requirements to be particularly positive," Christine Simmon, AAM senior vice president for policy and executive director of the Biosimilars Council told Medscape Medical News.

"This really was the floodgates opening," said Ron Lanton, III, a Washington, DC-based attorney who studies regulatory policy and has represented primarily small pharmacy chains.

"The United States is not an easy place for doing business when you're talking about biosimilars," he told Medscape Medical News.

The FDA has approved 26 biosimilars, including two insulins which, to date, have been labeled "follow-ons", Basaglar (insulin glargine, Lilly) and Admelog (insulin lispro, Sanofi), as they were brought to market under a different regulatory pathway, but are considered to be copycat or biosimilar versions of the respective branded insulin products.

The guidance "is one step forward for manufacturers" to say, "now that we know what the rules are, we can start to compete," said Lanton.

He believes the draft guidance, if ultimately adopted, will get biosimilars to market faster.

Dave Clissold, a food and drug lawyer with Washington, DC-based Hyman Phelps McNamara, which has represented biosimilar and branded insulin manufactures, also believes the policy will speed up new product development.

Also important, said Clissold, is the FDA's decision that manufacturers won't necessarily have to conduct studies that compare immunogenicity to the reference product.

That goes further than what had been expected but will be welcomed by biosimilar makers, Clissold told Medscape Medical News.

The FDA is communicating that "insulins are special biologics. They're small, they're not very complicated, we know a lot about them. There are all different types of insulins on the market right now, so we've got a ton of clinical experience with these things," he added.

Skipping those comparative studies won't be automatic, he said.

"But there is a path forward" that manufacturers can take to justify why they think they don't need to conduct what are usually costly and long studies, he explained.

Price Still a Question Mark

Clissold continued by noting that the FDA cannot dictate pricing, but ideally, "more competition will drive prices down."

"We've certainly seen that for the big blockbuster generic drugs," he said.

Lanton said that although the agency is attempting to harness competition to lower prices, that's not a given in the US market.

"We really don't know what the pharmacy benefit managers are going to do," he said.

Lanton pointed out the lack of transparency in the rebate scheme between PBMs and drug makers.

"What's going to prevent an innovator from coming in, talking to a PBM, and giving a steeper discount?" he said.

"Even if the price is lower, with the rebate still not being addressed, is that going to have an effect on anything?" Lanton wondered.

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