The House Committee on Energy and Commerce will hold an oversight hearing today, Feb. 4, on a new class of drugs, biosimilars, and the Food and Drug Administration’s (FDA) system for approving and monitoring them.

A biosimilar is highly similar to, but not an exact copy of, a biologic. Biologic drugs are complex therapies made from living organisms that are far more complicated and more difficult to develop and manufacture than traditional chemical drugs. Many are produced using a technology that extracts and combines DNA from plant or animal cells. Due to the uniqueness and complexity of biologics, they are impossible to copy in a generic form.

The introduction of biologic products to treat chronic and rare diseases has been the most significant advancement in patient care in recent decades.  These drugs have provided many patients an effective therapy, some for the first time in their lives.  

However, the complexity in the development and manufacture of biologic drugs means that they are typically costly. To help American patients better handle the expense of biologics, Congress passed the Biologics Price Competition and Innovation Act (BPCIA) as a provision of the American Care Act (ACA.) This provision allowed for the introduction of biosimilars to the prescription drug market under the theory that a biosimilar could provide some of the same medicinal therapies of a biologic for a lower cost.

The BPCIA assigned biosimilar approval and regulatory responsibilities to the FDA. However, the FDA has yet to issue guidance pertaining to many critical issues surrounding biosimilars. As more and more applications for biosimilar approval are filed, the FDA is still developing the standards for the approval and monitoring of these drugs. The agency is currently reviewing five biosimilar applications, and has issued approval for Zarxio, the first biosimilar in the United States, despite the lack of these regulations.

The intricacy and delicate nature of biologics call for biosimilars to be carefully tested and put through a scrupulous approval process at the hands of the FDA. Patient safety, confidence, and general interest must come first and foremost and it is imperative that the FDA develop and enforce necessary standards to ensure that these complex medicines meet rigorous standards for safety and efficacy.

Congress and the FDA can help to protect patient safety through a number of measures. Final guidance regarding crucial patient safety issues must be issued. Among these include standards addressing the labeling of biosimilars and the parameters in which they can be considered “interchangeable” with a biologic. Additionally, there must be a focus on the needs for education and clear information regarding biosimilars. Furthermore, a robust market surveillance system to track adverse effects must be established as should processes and frameworks to receive and act on patient feedback.

Biologic drugs have allowed for great advances in the treatment of complex, chronic and rare diseases. Biosimilars have the potential to expand these advances, but the patient’s best interest must be the first priority.

It is imperative to building patient confidence that Congress take steps to guarantee that there are strong and clear standards for review and processes in place to protect patient safety and ensure efficacy of biosimilar drugs before decisions about the applications are made.

LaMotte is the vice president for Public Policy at the Immune Deficiency Foundation (IDF), a national non-profit patient organization dedicated to improving the lives of patients with primary care immunodeficiency diseases.

Online at: http://thehill.com/blogs/congress-blog/healthcare/268066-fda-must-put-patients-first-in-biosimilar-approval-process

 

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