BioRationality: In FDA We Trust—A Commentary on FDA Efforts to Educate Biosimilar Stakeholders

The FDA provides educational resources and guidance documents to help stakeholders understand biosimilars' regulatory requirements and processes, including biosimilar sponsors, health care professionals, and the public. These resources include guidance documents, webinars, workshops, and educational materials. The FDA must do this under the Biosimilar User Fee Act (BsUFA) reauthorization commitment for fiscal years 2023 to 2027 (BsUFA III).

The education program by the FDA provides information to patients, industry, and health care professionals that includes extensive multimedia materials, and even a degree program on biosimilars. The agency also has been researching to resolve issues regarding interchangeability clarity, immunogenicity testing, and clinical efficacy testing, as well as challenges with leveraging real-world evidence, including health data derived from medical claims, electronic health records, data captured using digital tools, data from registries, and other sources to support safety and efficacy of biosimilars.

Another thing the FDA does is tell upfront on the first page that the guidelines are neither binding on the FDA nor the developers, giving the developers the right to present arguments that may differ from the suggestions in the guidelines.

The FDA is rewarded for how many biosimilars they approve, rather than the amount it rejects. However, their consideration does not include the development cost; it only considers safety and efficacy. On this basis, the FDA has removed animal toxicology testing, waived efficacy testing for many biosimilars, removed the need for immunogenicity testing if its variations do not impact the pharmacokinetic profile, and declared that interchangeability testing may be a redundant exercise.

However, despite these transparent efforts by the FDA, the stakeholders—including associations representing biosimilar developers, learned societies, drug distributors, media opinion leaders, and an unlimited number of presenters at hundreds of conferences—present their views about biosimilars, starting with the tiered pyramid that, in my opinion, should be retired.

When the FDA has already done the job for every stakeholder—from clinicians to patients—why are efforts for stakeholders to teach each other about biosimilars so encouraged? Is it because they have not kept up with the FDA education?

Taking a step behind, these stakeholders are teaching incorrect and fallible information that is intended to create more polarization, confusion, and doubts in the minds of others—in my opinion, this is intended for hidden political reasons such as keeping the interchangeability status, insisting on extensive efficacy testing, and keeping CMS out of price negotiation when the originator’s market exclusivity expires, even for the Medicare beneficiaries.

Unfortunately, such efforts do not go unnoticed—keeping the ignorance about biosimilars alive and thus keeping the vested interests active. An excellent example of such efforts is the claim made by key report makers, biosimilar associations, and others that adopting biosimilars will reduce costs. This should not be a piece of news; this is expected. And when combined with the slogan “more you buy, more you save,” which is found all around during the Christmas season, it is redundant and should not be the main reason behind biosimilar adoption. I think the most important reason to adopt biosimilars is that they are a clinically equivalent alternative to the reference product.

While many stakeholders will refute my opinion, I can convince them to leave education in the hands of the FDA if they have no vested interest. If that is the case, we should just mute all others and perhaps, they should stay mute.