Patient Voice is Paramount to New FDA Approval of Biosimilars

The Senate Committee on Health, Education, Labor and Pensions (HELP) held an oversight hearing yesterday on the Food and Drug Administration’s (FDA) system for approving a new class of drugs – biosimilars. The hearing was a significant step in making sure that the focus of the biosimilar approval process is on what is best for patient health.

Biologic drugs are a relatively new and unique category of pharmaceuticals – they are derived from living organisms and are far more complex and difficult to produce than traditional chemical drugs. For patients diagnosed with everything from immunodeficiency diseases to rheumatoid arthritis and psoriasis, biologic drugs are life-changing and are expanding treatment opportunities previously thought impossible.

As part of the Affordable Care Act, Congress created an abbreviated pathway to market for so-called “biosimilar” drugs.

Biosimilars are medicines that are similar but not identical to biologic drugs. Biosimilars should not to be confused with a generic copy of a drug, like those manufactured in traditional chemical pharmaceuticals.

Biosimilars have the potential to offer a vast new array of treatment options for patients. However, the complex nature of biologics means this new category of drugs needs to be carefully tested and put through a rigorous approval process at the hands of the FDA.

In March, the FDA approved Zarxio, the first biosimilar in the United States. Currently, the FDA is reviewing five more biosimilar applications. It is imperative the FDA put in place the necessary measures to make sure these medicines meet rigorous standards for safety and efficacy.

Patient safety, confidence, and general interest must come first and foremost.

A few weeks ago the FDA issued its guidance that all biosimilars should have unique and non-proprietary names in order to be clear which drugs are biosimilars. PBSA was very pleased with that decision.  However there is more work to do. The FDA, and Congress in its oversight capacity, can help ensure patient safety through a number of measures, including around the labeling of biosimilar products, setting strict parameters on which biosimilars can be listed as “interchangeable” with the biologics they replicate, focusing on the needs for education and clear information about biosimilars,  developing a robust pharmacovigilance post market surveillance system to track adverse events and establishing transparent processes and frameworks to receive and act on patient feedback.

Biologic drugs have already drastically changed and improved the way we treat a multitude of afflictions, and biosimilars have the potential to expand that success.

Patients for Biologics Safety &Access is a coalition made up of more than twenty patient advocacy organizations and is dedicated to ensuring the patient voice is heard by the FDA as it works through the biosimilar approval process.

The hearing held by the Senate HELP Committee was a good start in making sure that goal is achieved, but we cannot stop there. The patient’s best interest must be the first priority.


Larry LaMotte is the Vice President for Public Policy at the Immune Deficiency Foundation (IDF), a national non-profit patient organization dedicated to improving the lived of patients with primary immunodeficiency diseases.

Morning Consult