Similar to earning the public’s trust and confidence on generic drugs more than 20 years ago, the biosimilar industry needs to work to establish the same pattern of trust and confidence now, Janet Woodcock, director of the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research, told attendees at the Generic Pharmaceutical Association’s (GPhA) biosimilar conference in Bethesda, MD, on Wednesday.
Bluntly put, Woodcock said biosimilar and other industry and FDA staff had vastly different understandings of the Biologics Price Competition and Innovation Act (BPCIA) when it passed, and though those disagreements have been largely settled, now, she said: “We need to understand that it’s taking prescribers and patient communities more time to work through these concepts.”
Addressing critics of biosimilars head on, Woodcock acknowledged that there “are a lot of voices saying they’re not safe and effective,” and it will take a while for opinions to shift.
One of the main criticisms, seen in the public comment periods of the two most recent FDA advisory committee hearings for the biosimilars to AbbVie’s Humira (adalimumab) and Amgen’s Enbrel (etanercept), is this idea of “non-medical switching,” which centers on the idea that switching between a biosimilar and reference product is not medically necessary or justified.
However, Hillel Cohen, Ph.D., executive director of scientific affairs at Sandoz Biopharmaceuticals, made clear on Wednesday that “non-medical switching” is merely a buzzword and does not apply to biosimilars. As far as the unwanted immunogenicity concerns often raised as a potential problem for biosimilars, Cohen clarified that the “theoretical concern [for the biosimilar] is far, far less than what existed for the reference product when the reference product was first approved.”
Similarly, Woodcock explained that because of the more advanced analytical science that biosimilar developers are using, both FDA and industry have learned “a lot on the reference products we didn't even know when we approved them.”
And though it’s difficult to predict the actual growth of the US biosimilar industry over the next five years (estimates range from tens of millions to hundreds of millions), and there are still details that need to be ironed out on the naming and labeling of biosimilars, as well as what an interchangeable biosimilar really means, "great science and innovative regulations will get us where we need to be," Woodcock said.
Bert Liang, chairman of GPhA’s Biosimilars Council and CEO of Pfenex, added in a statement:
"As Dr. Woodcock stated, patients, physicians and pharmacists can be assured that FDA approved biosimilars are just as safe and effective as their brand biologic counterparts. An important point was raised, the success of this burgeoning industry will rely on educating and earning the trust of patients and providers."