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Experts Call for More Regulatory Action to Address Biosimilar Interchangeability Confusion


A panel of experts details the current concerns regarding interchangeability designations for biosimilars in the United States and calls for regulators and policy makers to make changes to allow to easier access to biosimilars and greater adoption.

Although they’re expected to help with establishing confidence in biosimilar efficacy, interchangeability designations will become a hindrance to biosimilar adoption if additional policy reforms are not implemented, according to a panel of industry experts.

During the panel discussion at the Association for Accessible Medicines’ (AAM) Access! 2022 Annual Meeting, the speakers dove into how to leverage competition among biosimilars and their reference products to allow for greater access among patients treated with biologic medicines and greater savings for patients and the health care system, according to Christine Simmon, JD, the panel moderator who is also executive vice president of policy and strategic alliances at the AAM and executive director of the Biosimilars Council.

Interchangeability designations are a regulatory label unique to the United States that allows for a biosimilar to be exchanged for a reference product automatically at the pharmacy level without requiring physician permission. Companies can obtain interchangeability for their biosimilar by submitting additional data to the FDA that they collect from switching studies.

However, because more data are required for authorization, many stakeholders incorrectly assume that interchangeable biosimilars are more safe or effective compared with other biosimilars. Additionally, fears regarding nonmedical switching, where patients are switched to a new medication like a biosimilar without a clinical reason, have led to several states, including Florida where the panel was held, to implement legislation that prevent such a switch unless the product is indicated as interchangeable, which can create a lot of problems for pharmacists.

“[Let’s say] a physician writes an order and it comes to my pharmacy. It may require authorization processes or that physician may have written for a biosimilar that I don't have on the shelf. I may have a different biosimilar on the shelf. All of this works to slow down the care process and requires increased interaction with physicians, time for them to turn around orders or reauthorize in some cases, and additional inventory dollars on our pharmacy shelves,” explained Steven Allison, PharmD, vice president of pharmacy at AdventHealth Corporate.

Additionally, Steve Miller, MD, chief clinical officer at Cigna, explained how many European countries have tender systems instead of interchangeability designations, whereby companies will compete with their prices to be chosen by the government as a federally covered product for a designated amount of time. This means that when a new tender period begins, patients will be automatically switched from the old covered product to the new one.

“The biosimilar savings there are extraordinary, and they don't even think about it anymore. It's just the drugs are interchanged because they don't have to have an interchangeability designation like they do in this country. And so, we have got to figure out how we're going to adapt some of the policies they've used if we're going to be successful,” Miller noted.

Furthermore, Martin Arès, vice president of biosimilars and specialty at Sandoz, expressed a growing need to sort out issues regarding interchangeability confusion prior to the introduction of adalimumab biosimilars referencing AbbVie’s Humira, beginning in early 2023. So far, the FDA has given 1 of the 7 approved adalimumab biosimilars an interchangeability designation (Cyltezo).

“We're getting close to a very important wave of new products that will be sold or distributed to retail pharmacies. And it's really, really important that decision makers who are responsible for driving formulary positions do not just use interchangeability as a criterion for exclusion for other biosimilars. And it's important because 2023 will be a pivotal year for the use and adoption of biosimilars,” said Arès.

Miller echoed Arès’ concerns and issued a call to action for regulators and policymakers at all levels of government to pull together and get rid of barriers and confusion related to interchangeability designations and nonmedical switching.

“Appropriate legislation and regulation at the federal and state levels are going to be crucial. And the FDA has done, in my mind, a really poor job of making us able to get to interchangeability…. I really believe we all have to be energized if we're going to be successful in changing the minds of people,” said Miller.

Bret Jackson, president of the Economic Alliance for Michigan, offered words of hope as he called for greater collaboration to implement policy and regulatory changes that will ultimately improve biosimilar access and adoption.

“It's a team sport. So, let's get together. Let's figure out how to attack some of these policy issues, attack interchangeability, and make sure that there aren't further barriers being put in place. Let's do it all together,” said Jackson.

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