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FDA Needs to Provide Guidance on Biosimilars | Commentary

By Louis Tharp When Congress passed the Biologics Price Competition and Innovation Act in 2010 as a part of the Patient Protection and Affordable Care Act, it created an approval pathway for biosimilars and interchangeable biologics. The BPCIA also gave the Food and Drug Administration the authority to issue guidance related to the approval of biosimilars and interchangeable biological products when it comes to naming, substitution, interchangeability and labeling. Unfortunately, we are still waiting for the FDA to finalize guidance five years later.  

Biologics are forms of treatment that millions of Americans depend on to treat their chronic diseases such as psoriasis, arthritis, cancer and chronic pain on a daily basis. Derived from living cells, biologics are designed to target diseases directly, not just their symptoms. The BPCIA allows for highly similar alternatives, called biosimilars and interchangeable biologics to enter the market.  

While the FDA has yet to issue any formal guidance, it has approved the first biosimilar in the United States.  

This issue has already received the attention of Congress. On April 30, nine members of the Senate Health Committee, led by Sen. Lamar Alexander, R-Tenn., wrote a letter to the FDA Commissioner Stephen Ostroff on the issue of naming. In their letter, the committee stated the “FDA has not provided sufficient guidance on important issues relating to the review and approval of license applications for biosimilar products, such as naming, interchangeability, and production of patent information.”  

Through our patient advocacy organization, Global Healthy Living Foundation — an organization representing more than 80,000 chronically ill patients across the country — we have been advocating for the FDA to finalize guidance in the areas of naming and interchangeability. Our goal is to ensure that the implementation of the BPCIA is done in a patient-centric way. We have done this by sending letters to the FDA regarding naming, testifying in state legislatures across the country, discussing substitution and sharing our stories through social channels and media. The GHLF recently participated in a policy briefing on the Hill alongside policy and medical experts and other patient advocacy organizations to outline the importance of biologics and biosimilars to our patient member community. Our efforts have not gone unnoticed, as progress has been made, and we look forward to our continued successes moving forward.  

While the other aspects of biosimilars are continuing to be discussed among federal and state elected officials, the issue of labeling is one that has not garnered the attention it deserves. This is the “fine print” that is included inside the package of your prescription with instructions, drug facts and clinical data. Labeling might not seem like a patient issue at first glance, but that is not the case. Given that biosimilars can never be replicated to be exact copies of biologics, even if they are deemed interchangeable, they can never be identical to biologics. Biosimilars require their own unique clinical data and applications to the FDA, therefore, it only makes sense that the FDA provide guidance requiring all of that information provided on the biosimilar’s distinct label as well as an indicator that it is a biosimilar.  

Not only does the biosimilar specific data on the label promote transparency, it also helps to maintain patient safety. Physicians need to have access to more information, not less, about the biologic and biosimilar drugs patients are taking because it makes a difference in ensuring the drugs the patients receive are the best treatment options for them.  

Patients want their doctors to have all of the information at their fingertips to be able to make more informed decisions regarding their well-being. This will only be possible by ensuring that biologics and biosimilars have their own unique label, and I am sharing the GHLF’s voice with you because everyone should be made aware of these important drug decisions happening now that have implications on medical options and patient health for years to come.  

Louis Tharp is the co-founder of CreakyJoints, RedPatch and CreakyBones, which are now a part of the Global Healthy Living Foundation, a patient advocacy and access to care organization.  


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