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This week (November 13-17) is the fourth annual Global Biosimilars Week, a social media campaign designed to raise awareness of the potentially life-changing impact of biosimilar medicines. To celebrate, we’re shining a light on Fran Gregory, PharmD and VP of Emerging Therapies at Cardinal Health, who is responsible for emerging therapies (including cell and gene therapies as well as biosimilars). In particular, Gregory is driving the company’s biosimilars business strategy, using the depth and breadth of Cardinal Health’s offerings and expertise to increase access to biosimilars, help lower healthcare costs and improve access to life-saving medications.

From the time Gregory was a pharmacy student, she knew she wanted to have a positive impact with her career. “What interested me in the field of pharmaceutical therapies and pharmacy were the positive patient outcomes made possible by medicine,” said Gregory. “I wanted to be part of that innovation, bringing the best treatments to patients and helping navigate the complexities of the healthcare system to make sure that the right patients get the right treatments when they need them.”

After earning her earning a bachelor’s degree in pharmacy, she pursued a Doctorate in Pharmacy and then, several years later, an MBA. “I wanted to understand not just the what of medication delivery and impact on patients, but the how. How do we get medications to those who need them the most, and how do our organizational, political, and regulatory structures support that mission?”

Since the launch of the first biosimilars – highly similar products to FDA-approved biologics – Gregory has seen the impact they can have on patient access and affordability. Biologics and their biosimilars are made from living cells, unlike conventional drugs. This makes them often more volatile, often more expensive to produce and more difficult for patients to access.

“For biosimilars, the strategy is to bring more competition to the healthcare ecosystem by providing more options for payors, prescribers and patients, lowering healthcare costs and creating a more sustainable healthcare ecosystem. This optionality will ultimately lead to enhanced access and overall improved affordability so that patients can get the medicines or treatments they need.”

Gregory and her biosimilars team have extensive expertise in the biosimilars space. Prior to joining Cardinal Health, Gregory was Executive Director and Head, Medical Market Access & Advocacy at Novartis. Earlier, she held roles at both Humana and Anthem, where she worked in biologic drug strategy, specialty pharmacy and pharmacy services and strategy. “Biosimilars are an exciting space to be in. You can really see the positive impact that biosimilars can have on the healthcare ecosystem.”

Each year, Cardinal Health publishes a Biosimilars Annual Report, outlining the overall biosimilars landscape for the past year and what to expect in the coming year, including data, trends and analysis. For example, the most recent report showed that the rates of biosimilar adoption are affected by the willingness of prescribers to prescribe biosimilars, and that willingness may be impacted by whether a particular biosimilar has an interchangeability designation. Also, participating rheumatologists cited interchangeability as one the most important product attributes for prescribing an adalimumab biosimilar. Additionally, in August 2023 Cardinal Health published a piece on the current biosimilars landscape, with added focus on biosimilars for Humira that have launched in the past year.

Gregory points to the two most important milestones/impacts that we have seen in the biosimilars space in the past year:

1. Humira (Adalimumab) Biosimilars: We have been closely monitoring the marketplace for Humira® biosimilars. “This past summer has been a milestone for biosimilars, especially for Humira®,” said Gregory. Since the release of our article on how Humira® biosimilars will change the healthcare industry came out in August, we have seen the marketplace change and adapt to these new therapies. Currently, there are eight biosimilars for Humira® on the market, with more expected to be released before the end of the year. As Humira® is the top-selling drug in the world, we anticipated that many biosimilar pharmaceutical manufacturers would be interested in entering this space with competing products, and that has come to fruition. “Looking forward, we anticipate that more of the most popular and highest-selling drugs will be the target of manufacturers looking to create biosimilars,” said Gregory.

2. Interchangeability: Interchangeability is a designation from the U.S. Food and Drug Administration (FDA) that allows a pharmacist to change out a biologic for a biosimilar, much in the same way a conventional drug can be automatically switched by a pharmacist to a generic version. Interchangeability is an FDA-specific designation; other countries do not have the same requirements. “The need for biosimilar manufacturers to obtain an interchangeability designation for their products can be a costly and time-consuming endeavor. Some manufacturers end up not pursuing an interchangeability designation for their products because of the additional investment needed,” said Gregory. In the U.S., there is proposed legislation to expedite regulation or even remove the need for an interchangeability designation altogether, which would help in getting more biosimilars into the healthcare marketplace more quickly.

Moving forward

In the future, Gregory sees positive momentum that should only increase as more biosimilars become available for more and more treatments. “I’m enthusiastic about the way things are going. An ever-expanding amount of biosimilars for different high-cost therapeutics means increased competition, which will lower overall healthcare costs as it relates to these complex biologic medications.”

For more information on biosimilars, visit the Cardinal Health website.