Sandoz, Boehringer Ingelheim Battle Biosimilar Misinformation

Two executives at Sandoz and Boehringer Ingelheim, both biosimilars companies, have taken aim at what they call disparaging information about biosimilars that weakens provider and patient trust in these lower-cost products and slows uptake and access.

In an opinion article published in the biologic therapies journal BioDrugs, Hillel P. Cohen, PhD, executive director of scientific affairs for Sandoz, and Dorothy McCabe, PhD, FCP, executive director at Boehringer Ingelheim, contended that public willingness to accept biosimilars is undermined in numerous ways by how these drugs are referenced in literature and clinical practice.

“Biosimilars are not well understood by many health care professionals and patients. The knowledge gap is exacerbated by disparagement of biosimilars and dissemination of misinformation, whether intentional or otherwise,” they wrote in their coauthored analysis.

Both Cohen and McCabe are members of the education committee for the Biosimilars Forum, a biosimilar promotion collaborative whose membership includes 9 of the largest biosimiliar producers, including Biogen, Coherus BioSciences, Merck and Co, Pfizer, Fresenius Kabi SwissBioSim, Teva, and Samsung Bioepis.

The issue of biosimilar characterization is a hot button currently. In a workshop early this year, the FDA and Federal Trade Commission pledged to work harder to combat what they described as deliberately misleading literature and descriptions of biosimilars that amounted to anticompetitive behavior by companies that market the original drugs upon which biosimilars are based.

And a recently published article that compared biosimilar filgrastims in an unfavorable light with the originator product, Neupogen, drew heavy fire from European biosimilar development consultants who contended the study stood on a very weak scientific platform and overlooked much accumulated evidence in support of biosimilar safety and efficacy.

Is the Playing Field Level?

The disparaging way biosimilars are often characterized does not allow them to compete on a fair basis with originator products, Cohen and McCabe wrote. This mischaracterization is directly counter to positions on biosimilar quality and value espoused by the regulators that approve them, they added.

Sometimes the fault is not in any intentional mischaracterization, but in the common terminology for biosimilars, according to Cohen and McCabe. The term “biosimilar” implies “a difference of some sort,” and the “abbreviated licensure pathway” used to approve biosimilars in the United States suggests that the approval process is “less rigorous or ‘more relaxed,’” they wrote.

Similarly, the concept of “nonmedical switching” is used to describe transitioning patients from a reference product to a biosimilar, when in fact the medical process has not been suspended. The patient is actually continuing the same treatment but with a different brand, Cohen and McCabe argued.

They observed that when it comes to clinical data, the requirements for biosimilar approvals are somewhat different. Biosimilar developers need to establish equivalence to the reference product using "analytical analysis as the foundation and clinical safety and efficacy studies…as needed.” This is vastly different from the requirement for phase 3 safety and efficacy studies for each indication for an originator biologic.

The problem is that health care practitioners may tend to expect the same type of data to be available on biosimilars as for originator products, Cohen and McCabe wrote. “While the clinical data package supporting biosimilar approval is more streamlined compared to the reference product, the overall data package is equally rigorous.”

Similarly, approved biosimilars can be used in all the settings indicated for the originator drugs without the need for studies in each indication. “Extrapolation of indications is based on structural and functional similarity and [pharmacokinetic/pharmacodynamic] data, and not between the indications of the reference product,” they wrote.

Inaccurate Claims

Beyond misleading language and misconceptions, in Europe inaccurate claims have been made about the reliability of pharmacovigilance monitoring of biosimilars, and it is often incorrectly stated that interchangeability is a higher standard for biosimilar approval than biosimilarity, Cohen and McCabe contended.

“The quality standards for biosimilars and interchangeable biologics are absolutely identical,” and although an interchangeable stamp would allow a pharmacist to substitute a biosimilar without consulting the physician, physicians are perfectly free to switch between reference products and biosimilars even if the biosimilar does not have interchangeable status, they noted.

Providers can help support biosimilar use simply by employing body language that expresses confidence in these products or by choosing their words carefully to avoid framing biosimilars in a negative way, the authors wrote.

Doctors, too, are influenced by wording more than they may realize. “This was quantified in a survey that reported that 60% of EU physicians were either very comfortable or comfortable in switching of stable patients to biosimilars, but when the very same question was posed with the phrase 'non-medical switching' inserted, the percentage declined to 42%,” Cohen and McCabe wrote.

With patient access to more affordable medicine at stake, biosimilar advocates must be vigilant, they concluded. “Biosimilar disparagement and misinformation will continue unless it is challenged; we cannot ignore these activities. It is the responsibility of all stakeholders to challenge biosimilar disparagement and misinformation when encountered.”