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Understanding the Challenges of Biosimilar Interchangeability
Philadelphia, PA—With the first biosimilar now available in the United States and more projected, the challenges posed by this new drug class needs to be addressed. Just as generic drugs require an understanding of interchangeability with branded agents, biosimilars need the same understanding relative to biologics.
“The pending launch of biosimilars is prompting many groups to weigh in on when and how these new types of medications should be considered interchangeable, including what standards should be set by the Food and Drug Administration (FDA),” said Steven Lucio, PharmD, senior director, Novation. “This ongoing discussion is likely creating a lot of confusion.”
In an effort to clarify, Dr Lucio spoke at the recent Biosimilars 20/20 meeting on how to overcome the challenges of interchangeability. Jeff Casberg, MS, director, clinical services, IPD Analytics, opened the session by describing some of these issues. IPD Analytics, opened the session by describing some of these issues.
An interchangeable biosimilar is one that can be alternated with the originator biologic product without any loss of efficacy or change in risk of adverse events. In addition, no intervention by a health care provider is needed to substitute such a product at the pharmacy level. In order to be considered interchangeable, a biosimilar must show equivalence to the reference product.
According to Mr Casberg, a challenge with biosimilar interchangeability is the lack of clear guidance from the FDA on the criteria to establish interchangeability and how to name these products. A number of states have introduced or passed laws on biosimilar substitution or interchangeability. However, the legislation is often poorly worded and fails to clarify the difference between biosimilars and interchangeables. Additionally, it is limited by a lack of federal guidance.
Managed care needs to capitalize on the opportunity to use interchangeables appropriately so they can incentivize and educate members and providers.
Data from a survey of 277 providers showed only 22% were moderately or extremely familiar with the issue. Finally, Mr Casberg emphasized the wide range of savings estimates, which is a combined average of about $100 billion over 10 years.
Dr Lucio highlighted the importance of understanding exactly what the term “interchangeable” means. In actual prac- tice, the approach to interchangeability and substitution is very nuanced.
Although generic medications deemed equivalent to branded medications by the FDA can be substituted by pharmacists without prescriber intervention, Dr Lucio said that prescribers and pharmacists may choose not to substitute certain products, such as anticoagulants or immunosuppressants.
“In addition, particularly within the hospital environment, physicians and pharmacists evaluate medications and designate certain products as therapeutically interchangeable even though they are chemically distinct,” said Dr Lucio. Compared to small-molecule generics, he said, the addition of interchangeable biosimilars to health system formularies will require a more involved process. The Pharmacy and Therapeutics Committee will need to evaluate in detail safety, efficacy, and more complex mechanisms for prescribing, administering, and documenting.
Dr Lucio emphasized that the formulary management infrastructure already exists to support decisions on biosimilar interchangeability; that health systems are comfortable using chemically distinct products in circumstances that are therapeutically similar; and that physicians and pharmacists are used to having access to clinical trial data to support strategies on interchangeability.
But he stressed that clinicians will need additional education on the role of analytical characterization in supporting the acceptance of biosimilar interchangeability.
“The FDA will ultimately establish the standard by which manufacturers pursue the interchangeability designation for their biosimilars,” Dr Lucio said. “While that will be a substantial component in determining the ease and frequency by which biosimilars can be substituted, it is not the only contributing factor.”
“Physicians, pharmacists, and others must understand the analytical, clinical, and regulatory information that substantiates interchangeability,” he said.—Mary Beth Nierengarten
