FDA Must Ensure Patient Safety Before Approving New Biosimilar

Breakthrough medicines known as biologics are turning debilitating and potentially deadly autoimmune diseases into manageable conditions. As the U.S. Food and Drug Administration (FDA) prepares to hold an advisory committee meeting next month to consider approval of a so-called biosimilar treatment – a drug that is like, but not identical to a biologic – however, there are serious concerns that must be addressed to ensure these new medicines do not compromise patient safety.

Autoimmune disease, which occurs when the body’s immune system mistakenly attacks the healthy body tissue it is meant to protect, is a major public health problem in the U.S. As many as 50 million Americans, primarily women, are currently living with an autoimmune disease – one of the leading causes of death in female children and women under 64.

Thanks to biologic medicines, an autoimmune disease is no longer life threatening.

Unlike chemical drugs, biologic medicines are made from living cells, uniquely equipping them to target the underlying cause of serious diseases – including cancers, HIV, hepatitis C, and autoimmune disorders. Biologics are complicated to produce and impossible to duplicate.

While biosimilar drugs are also made from organic material, they can never be the same or “generic” versions of biologics because biologics – by their very nature – cannot be replicated.

Due to the complexity of biologic medicines, they are more likely to be recognized by the body as “foreign,” a risk that is of special concern especially fraught for someone with an autoimmune disorder as they already have a higher level of immune response. As a result, patients with autoimmune diseases undergoing biologic treatment must be carefully monitored by a specialist to ensure the genetic makeup of the drug matches the specific needs of the patient. Any alterations in medication, no matter how slim, could have life-threatening consequences.

The American Autoimmune Related Diseases Association (AARDA) recently polled its members to assess their familiarity with biologic and biosimilar medicines. A majority of respondents – predominantly autoimmune disease patients – were aware of biologic medicines, yet more than half did not know how biologics differ from chemical drugs and over 80 percent said they were unfamiliar with biosimilars.

It is our hope that biosimilars will lower cost and increase patient access to new treatment options; however there are many safety issues yet to be resolved. The FDA has not issued clear guidance on the processes and standards for biosimilars specifically for naming, interchangeability and clinical testing.

In the interest of patient safety we support a policy that requires unique, distinguishable names for all biological medications to ensure accurate tracking of medication utilization and adverse events. We are still waiting for FDA to issue a guidance document regarding interchangeability. In addition, FDA should require that all manufacturers of biosimilars conduct rigorous testing to prove that the product works safely and effectively in each and every condition for which the manufacturer is seeking approval.

A new study recently presented at the Inflammatory Bowel Diseases 10th Congress of European Crohn’s and Colitis Organisation (ECCO) on a biosimilar to treat autoimmune diseases found that 80 percent of patients taking the biosimilar had to be readmitted to the hospital while only 5 percent of patients taking the originator biologic were hospitalized. Nearly 30 percent of patients who were treated with the biosimilar medication underwent surgery – a result that occurred in none of the patients who followed the originator biologic treatment. This study highlights just how much we still do not know about the impact of biosimilars on patients.

The FDA will soon hold its second advisory committee meeting to explore the viability of introducing this biosimilar drug in the U.S. But before this new treatment reaches pharmacies across the country, the FDA must address significant safety concerns about biosimilars in order to protect patients.

Patients fighting many and serious and life-threatening autoimmune disorders need their intricately formulated medicines to survive – and they depend on health officials to guide them to the safest and most effective treatments. Before approving a new biosimilar drug, the FDA has a critical opportunity in the upcoming advisory committee meeting to carefully consider the conclusions outlined in the European study.

All patients living with complex medical conditions need to understand this new category of drugs and be aware of their treatment options. AARDA has developed a patient-oriented white paper to educate patients about biosimilars and safety issues that need to be resolved before being approved. We trust that the FDA will continue to ensure safety first before these drugs are approved.



Virginia Ladd is President and Executive Director of the American Autoimmune Related Diseases Association (AARDA), a nonprofit health organization dedicated to bringing a national focus to autoimmunity.


Morning Consult