Patient Safety Must Be the First Priority for Approving New Biosimilars

The Food and Drug Administration will hold an Advisory Committee meeting today to approve a new biosimilar, the fifth drug approved by the FDA in this new class of treatments that are highly similar to, but not exact copies of, biologic treatments. While biosimilars have the potential to increase access to drugs that may improve the lives of patients, the FDA must first put in place critical guidances to ensure patient safety.

Biologics are complex drugs made from living organisms and are both larger and more complex than traditional chemical drugs — this size and complexity makes them impossible to copy in a generic form. To increase access for these treatments, Congress passed the Biologics Price Competition and Innovation Act, creating an expedited pathway for biosimilar approvals based on their level of similarity to the originator biologic they are developed from.

Congress established a separate and more rigorous standard for biosimilars that could be substituted for original biologic treatments at the pharmacy level to help ensure patient safety, called the “interchangeability” standard. Biosimilars are only labeled as interchangeable by the FDA after they have been proven to produce the same treatment result as their originator biologic in any given patient. To date, no biosimilar has been approved as interchangeable.

Biologic treatments are major advancements for patients that dramatically improve their lives and can help patients with chronic conditions, like rheumatoid arthritis, lupus or psoriasis, achieve stability. For these patients, changes in their treatment can increase the risk of adverse events and lead to worsened outcomes and potentially immunogenicity. Patients that develop immunogenicity to a biologic treatment may become unable to use not just the treatment that caused their reaction, but also any other related treatment. These kinds of setbacks can cause patients to lose years of progress in managing their diseases.

Recently, insurance companies and pharmacy benefit managers have implemented formulary changes that can result in stable patients being forced to switch to a biosimilar product, regardless of the interchangeability standard. This treats biosimilars as being interchangeable when they are not and undermines the will of Congress — under these circumstances interchangeability becomes meaningless.

Additionally, this forced switching is usually done to realize costs savings, not to improve patient outcomes. It is essential the FDA take steps to ensure stable patients are protected from non-medical switching. While the recent FDA guidance on interchangeability takes several important first steps, including requiring treatments seeking approval as an interchangeable product to provide data about switching between the originator biologic and the new biosimilar, more must be done for patients’ safety. Interchangeable products must be shown to be safe and effective for patients in a future marketplace with multiple biosimilars and interchangeable products for one originator biologic. In that marketplace, patients could be switched multiple times between several products over the course of their treatment. The FDA must ensure any switches a patient undergoes will not be dangerous or detrimental.

Finally, because biosimilars go through an abbreviated review process, the FDA must have a robust and comprehensive post-market tracking and reporting system to detect safety problems and adverse events that may occur with these treatments. The biologic originator of the product being considered by the FDA this week has a black box warning on its label due to its connection with a rare serious adverse reaction. This kind of rare but potentially fatal event shows the need for an aggressive post-marketing tracking system. All biosimilars, including future interchangeable biosimilars, should have distinct names to help with this tracking and to ensure patients using these complicated treatments are safe.

Patients must be able to have confidence in the new biosimilars approved by the FDA. To accomplish this, the FDA must put in place strong patient safety standers that ensure the efficacy of biosimilar drugs before approving new treatments to enter the market.


Larry LaMotte is the vice president for public policy at the Immune Deficiency Foundation, a national nonprofit patient organization dedicated to improving the lives of patients with primary care immunodeficiency diseases.

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