Gillian Woollett, MA, DPhil, senior vice president of Avalere and leader of the company’s FDA practice, told The Center for Biosimilars® in an interview that a study she co-authored is aimed at reassuring all biosimilar stakeholders that, “even though no clinical differences are expected when patients are switched from a reference product to a biosimilar, indeed none are found. Hence, we confirm the expectation already established through the application of sound regulatory science.”
This month, a systematic literature review published in Drugs1 presented findings that, in 90 biosimilar switching studies conducted in more than 14,000 individuals and involving 7 molecular entities used to treat 17 disease indications, switching to a biosimilar carried a low risk of safety issues or loss of efficacy, and was not inherently dangerous.
One of the study’s authors, Gillian Woollett, MA, DPhil, senior vice president of Avalere and leader of the company’s FDA practice, told The Center for Biosimilars® in an email interview, that the study is aimed at reassuring all biosimilar stakeholders that, “even though no clinical differences are expected when patients are switched from a reference product to a biosimilar, indeed none are found. Hence, we confirm the expectation already established though the application of sound regulatory science.” That confirmation, she says, can help all stakeholders feel more comfortable with biosimilars, even for patients who are established in their treatment with a reference biologic.
Asked why so many concerns about the safety of switching to biosimilars persist among patients and providers, Woollett said that “A new pathway was bound to be disruptive and raise all sorts of new questions.” This disruption was especially prevalent for those who had less experience with biologics, she added, as well as for those who had a lower level of awareness of the extensive use of the “high similar” analytical quality standard that has long been used to support manufacturing changes to biologics.
However, just as has been true in the European marketplace since the introduction of biosimilars, “a lot of the education [about biosimilars] comes through experience. Given the 30 biosimilar approvals and 700-million patient days of treatment with biosimilars in European nations, “We do not need to reinvent the wheel in the United States.”
Woollett emphasizes the fact that stakeholders in the United States can “capitalize on the global experience with the same biosimilars elsewhere if we organize that experience in high-quality peer-reviewed papers such as the one we have just published. It is a lot of work, don’t get me wrong, but it is crucially important to do, as most healthcare professionals do respect the peer-reviewed literature.”
In looking ahead to biosimilars designated interchangeable by the FDA, Woollett points out that, “as a scientific and regulatory matter, the approval of a biosimilar in the United States by the FDA is already supporting the clinical use of the biosimilar in the same manner as its reference.” She adds that, interchangeability will be “relevant to very few biologics, as most are administered by the physician who prescribed them,” and that a prescriber is free to use a biosimilar therapy if he or she chooses to do so.
“An interchangeable biologic is not a better biosimilar,” Woollett emphasized. “It is the same product already approved by the FDA on which additional clinical studies have been done.”
1. Cohen HP, Blauvelt A, Rifkin RM, Danese S, Gokhale SB, Woollett G. Switching reference medicines to biosimilars: a systematic literature review of clinical outcomes [published online March 3, 2018]. Drugs. doi: 10.1007/s40265-018-0881-y.