Two Healthcare Execs Back FDA on Biosimilar Names
American College of Rheumatology president Joan Van Feldt and Arthritis Association president Ann Palmer say that FDA should be allowed to do its job and implement transparency measures in biosimilar drug naming and labeling. “It is a common-sense decision that upholds the agency’s responsibility to protect the public health by ensuring the safety and efficacy of new therapies,” the write in a MorningConsult.com opinion column. “It will also help ensure patient safety, correct prescribing and dispensing, adequate post-market surveillance, increased prescriber confidence, and enhanced market uptake of biosimilars.”
The two note that some who oppose the use of different names for biosimilars, such as the Federal Trade Commission (FTC), argue that biosimilars are not that much different from biologics and so there should not be naming or labeling policies that make them appear meaningfully different from the reference biologics.
“The truth is there are meaningful differences between these therapies,” they write. “The international rheumatology community has years of experience studying and working with both original biologics and biosimilars, including many countries in Europe. At present, all of the evidence suggests that any changes in molecular structure, or something as simple as the administration method, could mean that a patient reacts differently to a biosimilar than to the reference, or originator, biologic. Therefore, prescribers need as much information as possible at their disposal to make treatment decisions that are in the best interest of their patients. Distinct names and transparent labeling for biosimilars will ensure this goal is achieved. At the heart of the FTC’s argument are concerns that distinct naming will hinder price competition and make physicians less likely to prescribe biosimilars in the future. They liken the situation to brand-name drugs and their generic counterparts, which are exact chemical duplications. In this situation, generics are less expensive versions of the more expensive brand-name products and often have little variation in product makeup and side effects. However, this is not the case with biosimilars. These therapies are much more complex and even slight variations can have a significant impact on the patient.”