Let the FDA Do Its Job to Ensure Safe Adoption of Biosimilars


When it comes to prescribing safe and effective therapies for patients, doctors need to know exactly what drug is being dispensed and patients need to know exactly what they’re taking.

This is especially true in the case of biologics, complex therapies developed from living cells that have made an enormous difference for patients living with rheumatic diseases like arthritis. While biologics have been a lifeline for many patients – helping them avoid serious health complications, long-term disability, and early death – they can come with serious side effects and adverse reactions if not properly managed.  Patients respond to different biologics in different ways, and so these therapies must be carefully tailored to the individual patient.

Often, biologic therapies need to be adjusted or halted in response to the patient’s evolving condition, and an alternate drug must be prescribed. Biologics are also made from living cells and cannot be reproduced exactly, further complicating patient safety.

It seems obvious to the Arthritis Foundation and the American College of Rheumatology that transparency in drug labeling is necessary to ensure the safe prescription, administration, and management of biologic therapies. Unfortunately, transparency is now on the line when it comes to the contemporary off-shoots of biologics, called “biosimilars.”

Biosimilars are comparable versions of biologics that have the potential to lower the cost of these life-changing – yet very expensive – therapies. This is good news both for patients who struggle to access and afford the biologic therapies they need to manage their conditions, and for the efficiency of the overall U.S. healthcare system.

But the introduction of biosimilars to the U.S. healthcare system also creates new concerns. Biologics are highly complex – made from living cells, not chemical compounds – and even small changes in the manufacturing process may have significant implications for patients.   As new biosimilars continue to emerge on the market, it is critical that doctors have as much information about the biosimilar product as possible, and that they are able to actively identify and decide between original biologics and biosimilars when making care decisions.

The  Food and Drug Administration is expected to release final guidance requiring separate and distinct names for biosimilars and biologic therapies. The move will allow for better transparency, making it clear to all parties involved – pharmacists, providers and patients – which drug the patient is receiving. It will also ensure that doctors have the clinical information they need to prescribe the most beneficial therapy to patients at the right time, and to monitor for any adverse side effects.

While the arthritis community supports FDA’s recommendations to apply distinct names to biosimilar products and make labeling as transparent as possible, opposition remains.

Some detractors, including the Federal Trade Commission, a consumer protection agency and not a science-based agency, have argued that biosimilars are not that much different from biologics, so we shouldn’t create naming or labeling policies that make them appear meaningfully different from their reference biologics.

The truth is that there are meaningful differences between these therapies.  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.

We are hopeful and optimistic that the introduction of biosimilars will lead to more treatment options, greater price competition and lower costs for patients. Rheumatologists and patients are excited about the possibility of using lower-cost biosimilar therapies to treat arthritis and other rheumatic diseases. But while more affordable care is a critical goal, it cannot come at the cost of patient safety. It’s best to proceed with full transparency as we work to bring safe, effective and affordable biosimilars to market.

The FDA must be allowed to 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. It will also help ensure patient safety, correct prescribing and dispensing, adequate post-marketing surveillance, increased prescriber confidence, and enhanced market uptake of biosimilars.

Most importantly, it will help us achieve our collective goal of improving the health and quality of life for the millions of patients across America who need these therapies.

Joan Von Feldt, MD, MSEd, is President of the American College of Rheumatology. Ann M. Palmer is President and CEO of the Arthritis Foundation. 

Morning Consult