The advent of biologic drugs has revolutionized treatment for millions of Americans, including those living with chronic and complex diseases such as HIV/AIDS, cancer, rheumatoid arthritis and other autoimmune diseases. As part of the Affordable Care Act (ACA), Congress paved the way for a new class of drugs, biosimilars, which as their name suggests are similar but not exact copies of originator biologic drugs.
Although biosimilars hold the potential to increase access to effective and affordable biologics, inaction by the U.S. Food and Drug Administration (FDA) over how the new drugs will be regulated have stoked patient safety concerns on behalf of vulnerable patients who rely on life-saving and life-sustaining biologic treatments.
By their nature, biologic drugs are extremely complex. They are derived from living organisms and are far more complicated than traditional chemical drugs. The complexity in both the manufacturing process and final product makes it impossible to copy these drugs exactly or to make a generic form of these treatments.
The complex nature of biosimilars requires a rigorous review process in order to ensure patient safety. As part of the Biologics Price and Competition Innovation Act (BPCIA,) Congress tasked the FDA with developing high patient safety and efficacy standards. The BPCIA mandated that the agency must develop rules for the naming, labeling and interchangeability of this new class of drugs. To date, the agency has yet to issue critical biosimilar guidance.
As part of their final guidance, the FDA should account for the current deficiency of education on biosimilars and the potential for lack of transparency in the marketing and selling of these treatments.
Further, the FDA must be sure that prescribers and patients have the full range of relevant information available to them when making treatment decisions regarding biologics and biosimilars. The FDA should develop policies that help patients, doctors, and pharmacists understand the specific risks involved with biosimilars, including a higher likelihood for adverse immune reactions and the potential for immunogenicity – an immune response that may cause a patient to stop responding to treatment altogether as consequence of a medication switch.
This is particularly important for those with autoimmune diseases, whose immune systems are particularly heightened and consequently may be more reactive to treatment changes.
It is becoming increasingly common for insurance providers to switch stable patients off of the treatments keeping them healthy to other, more cost-effective, therapies. These medication switches can result in devastating health outcomes, derailing and potentially backtracking patient care. It is the responsibility of the FDA to ensure that the regulatory system for biosimilars protects patients from these unnecessary and non-medically mandated medication switches.
Despite the ongoing lack of critical guidance for biosimilars, the FDA has already issued approval for two of these drugs. This week, FDA Advisory Committees reviewed two additional biosimilar applications. It is imperative that the FDA heed the patient and provider voice throughout the process.
Biosimilars have great potential to increase access to treatment for those suffering with chronic illness, but efficacy and patient safety – and not cost – must be the commanding factor in their approval.
Virginia Ladd is the President and Executive Director of the American Autoimmune Related Diseases Association, Inc. (AARDA.)