On Tuesday, December 10, during the 2019 ASHP Midyear Clinical Meeting & Exhibition, an educational session titled “The Rise of the Biosimilars: Increasing Use on a Broad Scale” assessed the current state of biosimilar medications from the regulatory and clinical perspectives.
Session presenters Karen McConnell, PharmD, BCPS, FASHP, FCCP, system director–clinical pharmacy services, Catholic Health Initiatives, Englewood, Colorado, and Patrick Ellis, PharmD, market director of pharmacy, CHI Memorial, Chattanooga, Tennessee, compared and contrasted the differences between biosimilar and generic medications and between reference biologic products and biosimilars. Drs. McConnell and Ellis also identified currently available biosimilars and those in the pipeline in the United States while evaluating the challenges of biosimilar therapy adoption among clinicians and patients.
Drs. McConnell and Ellis also remarked that biosimilars have the potential “to save the U.S. healthcare system $54 billion over 10 years and increase access for an estimated 1.2 million U.S. patients by 2025.” Today, they reported, 23 biosimilars have been approved and nine are available for use. In addition, they added, cost savings have been realized by patients, health systems, integrated delivery networks, and payers when switching to biosimilars.
Dr. McConnell asked attendees, “Why do we have so much reference product use and not more biosimilar use?” The answer, she said, is that is not easy to convert over to biosimilars. “There are so many stakeholders who have to work together to get us to where we need to be with biosimilars. It comes down to regulations: Generic drugs are regulated by the Hatch-Waxman Act, which helps generic manufacturers streamline the cost of launching medications, demonstrating bioequivalence, and provides assistance with patent-litigation issues,” she noted. “Biosimilars, however, are governed by the Price Competition and Innovation Act through the Affordable Care Act. This act actually makes it costlier to manufacture biosimilar and biologic drugs than generic drugs. The act mandates larger patient trials compared with those required for generic drugs, and it does not provide the patent protections enjoyed by generic medication manufacturers under Hatch-Waxman. “That litigation causes lots of uncertainty,” she lamented.
The session also instructed attendees how to strategically communicate with providers, pharmaceutical companies, management, and patients regarding important biosimilar issues. In addition, they described challenges involving third-party coverage of biosimilars and described barriers, such as rebates to insurers, to widespread biosimilar usage.
Dr. Ellis noted that there is confusion about the biosimilar approval pathway in general. To some clinicians, “this is a foreign entity, particularly if they don’t infuse medications in their own offices.” In addition, he added, “There is a ‘don’t rock the boat’ phenomenon where patients have been stable for long time periods of time and have concerns about switching those products.” Interchangeability is also a concern, Dr. Ellis added, and are cost concerns for patients.
Summing up, the presenters said that by supporting biosimilars, each stakeholder has the opportunity to be a part of the solution in “offering patients high-quality care at a more affordable price and creating a more sustainable system for patients.”
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