Biosimilars and their promise are creating excitement, but there is also a recognition that developers, physicians and patients must understand biosimilars better for that promise to be fulfilled.
John K. Jenkins, director of the Food and Drug Administration’s Center for Drug Evaluation and Research’s Office of New Drugs, addressed the buzz about biosimilars in his keynote address at the DIA 2016 Biosimilars Conference in Washington, which I covered for Bloomberg BNA. He said the FDA’s approval of four biosimilars since the Biologic Price Competition and Innovation Act of 2010 created the abbreviated approval process is driving the excitement.
He noted that the definition of a biosimilar is two-pronged: It is a biologic product that is highly similar to an already FDA-approved biologic product, and it has no meaningful clinical differences from that product.
And yet, Jenkins said, “FDA employs a step-wise approach to generate data in support of a demonstration of biosimilarity, but some biosimilar applicants seem to want to use a shotgun approach. You cannot overcome a lack of ability to demonstrate ‘highly similar’ with a demonstration of no clinically meaningful differences.”
He added that understanding this approach is still a work in progress for some.
Discussion of a recent survey at another conference session confirmed that education is still needed. It showed that some physicians had difficulty in defining biosimilars and didn’t seem to understand the regulatory approval process.
In addition, panelists at a session of officials from the FDA, Health Canada and the EU noted another hurdle: the differences in regulations regarding biosimilars from country to country. Applicants looking to market biosimilars in different countries should understand these differences prior to the initial launch, he said. My article on this session is here.
Biosimilars have the potential to bring less expensive versions of lifesaving biologic drugs to more and more people. It appears, however, that additional education about biosimilars will be needed if that is to happen.
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