Regulators and doctors must work together to ensure safety of biologic medicines

Biosimilars are the lower cost imitative versions of biological medicines, which are advanced therapies made in living systems.  These cutting-edge medicines treat non-Hodgkin’s lymphoma and several other cancers, Hepatitis C, and even Multiple Sclerosis.  Over 350 million patients worldwide have benefited from approved biologic medicines, and over 650 new biologic medicines and vaccines are being developed to treat more than 100 diseases, yet there are no “biosimilar” versions of these products available in the United States.

In 1984, when Congress enacted legislation ushering in generic versions of chemical drugs, biologics were not included as they were considered “too complex”.  Yet a provision in the 2010 healthcare reform package authorized the FDA to figure out how to approve biosimilars for cost saving purposes. The FDA is expected to issue its guidance, known as the “biosimilars pathway” by end-of-year.  Industry, physicians and patients are waiting intently to see what measures will be included.

{mosads}Patient safety is vital because biologics pose challenges above and beyond traditional chemical medicines.  Unlike traditional drugs that are made from chemicals, biologics are very complex compounds whose characteristics and properties are highly dependent on the manufacturing process. Due to their complexity, these compounds can sometimes have unexpected or even adverse effects in patients.

It appears the FDA recognizes the unique challenges of biologic and biosimilar medicines.  In its proposed recommendations for a biosimilar use fee program, it refers to the “nascent state of the biosimilars industry in the United States” and notes the “complexity and level of effort required for FDA oversight of manufacturing and post-marketing safety issues.”

Accordingly, to ensure patient safety and efficacy of all biologic and biosimilar medicines, the FDA will have to implement robust clinical and nonclinical measures.  This includes clinical trials, unique proprietary names to reduce medication errors and a track and trace system in case a patient accidentally gets sick from a medicine.  Above all else, we must ensure that the patient-physician relationship is maintained.  Only patients, in consultation with their physicians, are in a position to make critical medical decisions.

It is worrisome that upholding the patient-physician relationship has not been endorsed by the U.S. American Medical Association (AMA), the professional body of doctors that has large influence over national and state healthcare laws and regulations.  In a recent meeting in New Orleans, the AMA amended its position on biosimilar medicines, enabling a pharmacist to switch a patient from a biologic to its biosimilar version without expressed consent or even knowledge from the patient or the physician.  This policy is misguided because it could hurt patient choice and access to all biologic products and complicate patient safety.

As a physician residing in the state of California, I want what’s best for my patients.  We must ensure that all drugs are safe and work, no matter the cost. As biologic medicines are much larger and multifaceted compared to traditional medicines like Tylenol or cholesterol drugs, we cannot apply the same thinking to their approval process and policy guidelines.   So far it appears the FDA recognizes the importance of patient safety but it’s critical that physicians and regulators work together to ensure these measures are ultimately adopted.

Dr. Marcy Zwelling-Aamot, whose practice is in Los Alamitos, is the former president and current chairperson of the Board of the American Academy of Private Physicians (AAPP).