Biosimilars occupy a huge place in the oncology treatment conversation these days. But what are they exactly, and how will they impact clinical pathways?
Gary H Lyman, MD, MPH, professor of medicine, public health, and pharmacy at University of Washington School of Medicine, and Robert M Rifkin, MD, clinical associate professor of medicine at University of Colorado addressed these questions in a wide-ranging presentation given at the 2017 Clinical Pathways Congress.
Biosimilars are drugs shown to be highly similar to a reference product. They differ from generics, which are exact copies of their reference product, because they are produced by living cells and are constructed of large molecules. A mainstay of medical management in Europe for more than a decade, the FDA approved the first biologic product in the United States in 2015.
There are currently six biosimilar products currently approved by the FDA or in the approval pipeline, according to Dr Rifkin.
Data from Dr Lyman’s presentation show a marked increase in medication costs between 1965 and the present day, with the sharpest increases occurring within the last 15 years. Biosimilars, which provide a nearly identical product to reference drugs, are seen by many as a potential cost control measure as drug prices continue to rise. “Expensive treatments make appropriate cancer care a hardship of unaffordable,” Dr Lyman said.
But the interest in biosimilars has not come without some questions and knowledge gaps, according to Dr Rifkin. These include variability and drift, since no batch of biosimilars can be said to be exactly the same; immunogenicity concerns, which can have clinical consequences; and the potential for rare but serious adverse events. Pharmacovigilance will play an important role in the integration of biosimilars into standard clinical pathways.
“Postapproval pharmacovigilance for efficacy and safety of biologic agents is of particular importance when considering biosimilars,” Dr Rifkin said. “Biosimilar manufacturers should work early with the FDA to develop an approach.”
Drs Lyman and Rifkin believe that biosimilars will quickly earn a place in oncology clinical pathways as they continue to be approved by the FDA. However, they identified potential barriers to this adoption, including physician resistance, lack of patient incentive, and pushback from professional societies. Still, they found numerous benefits for adding biosimilars to the pathway conversation, including the addition of more low-cost treatment options to the oncology armamentarium; global savings for the health care system; the fostering of further research in the area of biologics; and equivalent or better overall health care outcomes.
“Do pathways add value?” Dr Rifkin asked. “I think they do. And pathways and biosimilars are a perfect fit.”