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Expert Opinion Roundup: New Insulin and Biosimilar Regulation


Opinion leaders discuss the significance of regulatory changes affecting biosimilar and insulin products.

In recent video interviews with key opinion leaders, The Center for Biosimilars® discussed critical issues, such as how insulins fit into the biologics’ regulatory framework, how payer policies affect provider freedom to use biosimilars, and the pace of regulatory review. Here’s an overview of these interviews.

Ted Mathias and Stacie Ropka, PhD, intellectual property law partners with Axinn Veltrop and Harkrider, discussed how insulin products will fare under the new regulatory pathway created via the Biologics Price Competition and Innovation Act (BPCIA).

“In one sense, it will be easier to seek a follow-on insulin product under the BPCIA because the pathway to biosimilarity has been established and has been successfully followed by both follow-on developers and FDA. However, for the foreseeable future, it will be time consuming and expensive to obtain approval under the BPCIA,” said Ropka.

Additionally, the new pathway means that patent litigations for insulin products may become more complicated as well.

“As patents on insulins, insulin formulations, methods of using insulin, and processes of making insulin all expire, reference sponsors are focusing on patents directed to systems of delivering the insulin. So, whereas before there was litigation involving drug patents on one hand and litigation involving medical device patents on the other, the lines are really blurring,” said Mathias.

Nick Mitrokostas, an intellectual property law attorney with Goodwin Procter in Boston and editor in chief of Big Molecule Watch, talked to us about his hope for new biosimilar approvals despite the apparent slowdown in FDA reviews as a result of the coronavirus disease 2019 (COVID-19) pandemic.

“I think we're going to see some more approvals. Maybe I'm being optimistic here, but I do think that FDA will be poised to approve some more biosimilars. I also think we're going to see a number of more filings, given [everything that’s going on] and that people have been describing in their public earnings calls and SEC filings some of the molecules that are nearing their expiration dates,” said Mitrokostas.

Mitrokostas also discussed how the FDA is assessing what biosimilars can be deemed interchangeable, a designation that would allow biosimilars to be exchanged for their reference products at the pharmacy level. Currently, there are no biosimilars with this designation; however, insulin products may bypass the requirement because of their lower complexity compared with other biologic products.

“Something that has 1 target and has low complexity may be easier to be demonstrated as interchangeable than a product that has high complexity and maybe has multiple indications and multiple targets in the body that might require more studies and more work to demonstrate interchangeability,” he said.

Anurag Rathore, PhD, coordinator of the Center of Excellence for Biopharmaceutical Technology in Delhi, India, discussed his recent study on biosimilar application failures, which found several reasons, including the FDA's regulatory standards, which could lead to rejected applications.

“If you keep asking for more comparative trials, or larger trials, then the whole thing becomes less attractive to a manufacturer, because then the biosimilar manufacturer ends up spending the same amount of money as the innovator. That is something I think, particularly, the FDA has to watch out for…and this becomes a hurdle, because not many companies can afford to give that kind of data,” said Rathore.

Nancy J. Globus, PharmD, vice president of Regulatory Affairs at the Accreditation Council for Medical Affairs (ACMA), discussed the purpose of 4-letter suffixes used in the United States for all new biosimilars, interchangeable biologics, and reference biologics. These help categorize large-molecule products while still distinguishing between products and allowing for adverse-event tracking.

Globus said that although some argue that suffixes cause confusion among prescribers and patients, there could be many reasons beyond naming why people might confuse these products.

“The name is only one of those issues that could cause confusion or error. There are practitioner and practice site—related issues, and on the industry side, we're just talking about the nonproprietary name. The brand name and what the package looks like could be a cause of confusion, too. So, we have to remember that there are a lot of causes of medication errors, including the fact that medication error reporting is voluntary,” she said.

Kathy Oubre, MS, chief operating officer at the Pontchartrain Cancer Center in Louisiana, president of the Louisiana Medical Group Management Association and a member of the board of directors for the Community Oncology Alliance, discussed how payers making formulary decisions without consulting providers complicates how practices function by making them carry multiple biosimilars for one reference product.

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