As more biosimilars come to market, the FDA must take steps to ensure patient safety

As more biosimilars come to market, the FDA must take steps to ensure patient safety
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Patients are about to have more choices when it comes to the treatment of chronic disease. Biosimilars are a new class of drug that have the potential to increase access to lifesaving treatments and reduce costs. Recently, the U.S. Food and Drug Administration (FDA) accepted applications for two biosimilars that would help treat breast cancer, and it is likely that additional applications are on the way. However, the new applications underscore the need for the FDA to first put in place critical guidelines to ensure patient safety.

Biologics are complex drugs made from living organisms and are both larger and more complex than traditional chemical drugs — their size and complexity makes them impossible to copy in a generic form.

To increase access to these treatments, Congress passed the Biologics Price Competition and Innovation Act, creating an expedited pathway for so-called “biosimilar” drugs, based on their level of similarity to the originator biologic from which they are developed.


Biologic treatments are major advancements that can dramatically improve the lives of patients and can help patients with chronic conditions effectively manage their health and achieve stability. For these patients, changes in their treatment can increase the risk of adverse events and lead to worsened outcomes and potentially to immunogenicity.

As more biosimilars come to market, major questions loom. What will the FDA do to assure patient safety when patients could get switched to and from multiple biosimilars? Will the new applications have to demonstrate biosimilarity to other biosimilars on the market in addition to the originator?

So far, the FDA has only approved seven biosimilars, but the increase in biosimilar applications and approvals means patients will have access to more medicines and additional treatment options. Additionally, more choice means more competition and therefore lower prices. While choice and cost-savings are good, the FDA must take steps to ensure that the biosimilars coming to market are safe, and that their use is regulated in order to protect patients.

Some steps have already been taken to assure safety – Congress established a separate and more rigorous standard for biosimilars that could be substituted for original biologic treatments at the pharmacy level, 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.

Recently, however, insurers have moved forward with formulary changes and other coverage changes that are forcing patients who are stable on their treatments to switch to non-interchangeable biosimilars, sometimes without prior notice. This could be dangerous for patients with chronic conditions who rely on treatments to manage their health, and further, it treats biosimilars as interchangeable when they clearly are not. Additionally, these non-medical switches usually happen only to realize costs savings, not to improve patient outcomes.

If this is behavior we are seeing with seven biosimilars on the market, then more steps need to be taken by the FDA to ensure that, as more treatments become available, stable patients are protected from non-medical switching, and that interchangeable products are shown to be safe and effective for patients in a marketplace with multiple biosimilars.

The FDA should issue guidelines that are designed to recognize and anticipate a future marketplace that has multiple approved biosimilars and interchangeable products for the same indications. These guidelines need to address a future where patients may be switched to and from reference products, non-interchangeable and interchangeable biosimilars over decades for the treatment of chronic conditions. The scope of required switching studies should consider this and account for the fact that many patients take biologics for chronic conditions for many years, and could be switched back and forth multiple times.

As more biosimilars come to market, patients need to know that their treatments they rely on are safe and up to standard with other drugs approved by FDA. To make this happen, the FDA must instill ironclad patient safety standards that ensure biosimilars are as safe and effective as the reference innovative biologics.

Lawrence LaMotte is the vice president of public policy at the Immune Deficiency Foundation, a national nonprofit patient organization. He is also the coordinator of Patients for Biologic Safety & Access, a coalition of 24 patient advocacy organizations interested in ensuring that patients have access to safe and effective biologic medicines.