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Policy & Medicine – The Uncertain Future of Biosimilars in the United States

Policy & Medicine – The Uncertain Future of Biosimilars in the United States

Friends of Cancer Research held an event, “The Future of the U.S. Biosimilars Market: Development, Education, and Utilization,” on Tuesday, October 18, 2016. The event was a half-day forum that brought together clinicians, originator and biosimilar drug sponsors, advocates, regulators, and payers in an attempt to tackle uncertainty surrounding the future of the United States biosimilars market.


As we have written about before, the 2009 Biologics Price Competition and Innovation Act (BPCIA) created an abbreviated licensure pathway, 351(k), for biological products that are shown to be biosimilar to, or interchangeable with, an FDA-licensed reference originator product. The regulatory requirements for biosimilars are significantly greater than those for generic drugs as biologics are far more complex than small molecule drugs. In 2012, the FDA issued the Guidance, Scientific Considerations in Demonstrating Biosimilarity to a Reference Product in 2012, and in 2015, the FDA released additional Biosimilarity Guidances. In 2015, the FDA approved Zarxio, the first biosimilar product submitted via the 351(k) pathway. However, questions still remain for the implementation of the biosimilar pathway in the United States, particularly for the development of monoclonal antibody (mAb). Several important biosimilar mAb therapeutics for treatment of autoimmune disorders and cancer are already in development or approved in other regions.


The discussion sponsored by FORC was divided into two panels, one on the regulatory landscape for biosimilar development and the other on clinical decision-making, coverage and reimbursement. Panelists represented a wide range of stakeholder interests, including biosimilar developers, the Food and Drug Administration (FDA), the patient community, benefit managers and payers, and professional societies.

Panel Discussion

During the first panel discussion, Dr. Leah Christl, Associate Director for Therapeutic Biologics at the FDA, noted that an interchangeability designation did not necessarily signify a higher standard than a biosimilar designation. Biosimilars are approved when they are shown to be “highly similar” with “no clinically meaningful difference” from the reference product, whereas interchangeability means that a prescription written for a biologic could be substituted at the pharmacist’s discretion for a drug that was therapeutically equivalent.


Dr. Christl believes that interchangeability will have large implications for manufacturers because it allows pharmacists the discretion to substitute one branded product for another. Dr. Carlos Sattler, Vice President and Health of Clinical Development and Medical Affairs at Sandoz, Inc., noted that a manufacturer’s decision to seek the interchangeability designation is more of a strategic decision, as it depends on the content of the additional information package required to be submitted to the FDA.


Audience members pointed out that two products that have clinical similarity and being able to demonstrate the safety of switching patients from one product to another during an ongoing course of treatment are two very different things. They expressed concern about switching patients, patient access to drugs, and continued cost restrictions.


During the second panel, Jeff Eichholz, the Senior Director of Drug Trends Solutions at Express Scripts, stated that biosimilars do have the ability to introduce high savings to patients, but it is extraordinarily important for patients to be able to maintain access to their original product if switching is not appropriate for their course of treatment. 


The panel also discussed CMS’ decision to group biosimilars paid for by Medicare Part B under the same billing code. Dr. Eichholz finds that approach to be a step in the right direction, but that there are concerns when the average price for one drug in the group was much different than others.


All panelists emphasized the importance of keeping biosimilars distinct for data tracking purposes about their long-term impacts, as well as the importance of patient access, especially for patients who were started on a specific product. Even still, despite the challenges for the future of the biosimilar market, all panelists and stakeholders still remain optimistic about the ability of biosimilars to bring down costs, while maintaining access for patients.…