A recent article from MedPage Today explored a provision in the healthcare reform bill that called on the Food and Drug Administration (FDA) to create an expedited pathway for approving biosimilars — the nonidentical “generic” versions of advanced prescription drugs to treat multiple illnesses from cancer to rheumatoid arthritis.
As we noted back in September, FDA is expected to issue guidance on the subject shortly. (Well, maybe not)
The primary concern for the FDA is how to ensure that a biosimilar is the same as its original biologic. Writing for MedPage Today, Bruce S. Rubin, MD, explained the “crucial differences that separate “generics” from biosimilars.”
He noted that, “Most traditional drugs, like Tylenol, are chemically synthesized, which means they have structures that are consistent and known. Biologics, on the other hand, are fashioned out of living cells, meaning they have much more complex structures, which are not as easily understood as the makeups of chemically created drugs.”
Dr. Rubin explained that, “Because a chemically created drug can be reproduced easily, the generic versions are no different than their name-brand counterparts and can be verified through testing and analysis.”
However, he noted that, “With biosimilars this is not always the case. That’s because biologics are more complex structures that are much more difficult to replicate. An error in reproduction could cause unanticipated or harmful side effects. This fact illustrates why the FDA needs to exercise added caution when setting out the process and priorities for approving biosimilar products.”
Dr. Rubin explained that, “Right now, no biosimilar exists on the U.S. market; because of their complexity, they weren’t included in the Hatch-Waxman legislation that set the regulatory framework for other generic drugs.” The Affordable Care Act however changed that, which led to FDA beginning to hold meetings last November to develop a biosimilar approval process.
In order to ensure the safety of biosimilar drugs for patients, Dr. Rubin recommended that the FDA:
- Require clinical trials or other appropriate clinical testing before the approval of biosimilars
- Ensure robust pharmacovigilance, the surveillance of a drug’s performance, including adverse reactions, after it’s been released for marketing. Of primary importance is the creation of a traceability system that includes distinctive labeling, product tracking codes, and a way to report adverse reactions
- Require different names for all biologic medicines in order to prevent confusion for physicians and patients
- Require transparent and clear product labels that educate patients about the trials conducted on that specific product, not just the reference product
- Guarantee that patients and their doctors have the ability to decide treatment by ensuring a treatment plan is not altered by a pharmacist without the consent of the physician and patient
Dr. Rubin asserted that, “Including these requirements would assure patients and their families that the FDA is set on striking the right balance between cost effectiveness and patient safety.”
He emphasized that, “biologics and biosimilars could revolutionize the way the U.S. treats some of the most painful, most deadly diseases. But like the advances that came before them, these new treatments must undergo a thorough evaluation process before their approval. Patient safety must be considered first if we are to uphold America’s system for pharmaceutical review and approval.”