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Biosimilars: Ambiguity of FDA Terminology and Benefits of a Multidisciplinary Review Team

TOP - February 2015, Vol 8, No 1

Because of the complexity of biosimilar regulations, a pharmaceutical and therapeutics (P&T) committee—which includes pharmacists and physicians—is recommended to determine appropriate biosimilar use, according to a presentation at the Oncology Pharmacy Education Network Pre-Conference of the Association of Community Cancer Centers’ 2014 National Oncology Conference, held recently in San Diego, CA.

Jim Koeller, MS, professor at the University of Texas at Austin College of Pharmacy and the Health Science Center in San Antonio, discussed the need to place the P&T committee front and center. In extolling its virtues, Koeller quipped, “A P&T committee is almost like god. They can say, ‘let there be light,’ and there is light.”

Promoting a case-by-case approach to the approval of a biosimilar, the US Food and Drug Administration (FDA) requires a biosimilar application to show that there are no clinically meaningful differences in safety, purity, and potency between the biosimilar and the US-licensed reference product. Analytical data, animal testing data, and clinical study data (including immunogenicity and pharmacokinetics/pharmacodynamics evaluation) must show that a product is “highly similar” or “biosimilar” to the approved biologic and at least approximates the original safety and efficacy.

Many Unanswered Questions
Koeller underscored the ambiguity of the FDA’s regulations: “How similar is similar enough to be defined as highly similar when it comes to a complex biologic?” he asked the audience rhetorically. “What structural difference will be compatible with the concept of highly similar? These questions are still open to interpretation.”

Although the FDA has released 3 draft guidances, many unanswered questions remain, especially with regard to interchangeability. The FDA views the biosimilar designation and interchangeable designation as 2 distinct steps.
“The product will first have to be deemed biosimilar,” explained Koeller. “Then the company will have to come back with additional data to obtain the interchangeable indication. This would indicate that a product will have to be on the market first as a biosimilar prior to its approval as interchangeable.” To be found interchangeable, a product must be expected to produce the same clinical results as the reference product.

How the federal statutory definition of interchangeability will mesh with state pharmacy laws dealing with substitution also remains to be seen. “A lot of this doesn’t make sense to the average person,” added Koeller. “Apparently, you have to be a government employee to figure it out.”

The patents of several major biologics are projected to expire in the next 5 years. However, because of the uncertainties regarding the “approval step approach” and all of the required data (including clinical review), Koeller suggested initial cost-savings may be only 10% to 20%.

Multidisciplinary Review Team: Include a Lawyer
Because of the nature of these products, a team that includes pharmacists and physicians will be needed for biosimilar review—a systematic review process that examines product, manufacturing, and institutional and patient factors. Rather than having 20 people who can never find the time to meet, Koeller suggested a core group of committee members, bringing in experts as needed on a product-by-product basis.

“This group needs to be multidisciplinary in membership,” said Koeller. “It needs to include pharmacists, physicians, nurses, businessmen, and lawyers.”

One of the P&T committee’s powers is the ability to deem a biosimilar interchangeable, even if that drug has yet to be deemed so by the FDA’s terminology. An institutional formulary committee can establish therapeutic interchange for products with a similar efficacy and safety profile, even if those products are chemically or structurally different. However, Koeller advised exercising caution when making therapeutic interchangeability decisions based on biosimilar data. “You can deem anything interchangeable,” he said. “You just assume the risk.”

“Put a risk manager and lawyer on your committee immediately,” said Koeller. “If we do this and there’s an issue, does your center want to take the liability? The whole reason for doing this is economic savings. Why make the change if you can’t save money?”

Koeller J. Implementing a biosimilars review panel at your institution. Presented at: Association of Community Cancer Centers 31st National Oncology Conference; October 8-10, 2014; San Diego, CA.

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