Positive impact: When considering ‘biosimilars’ legislation, Kentucky must ensure patient safety.

Stephen Marmaras

Stephen Marmaras

The positive impact of biologic medicines for the treatment of many chronic diseases, such as multiple sclerosis, HIV, hepatitis C, Rheumatoid arthritis and others, cannot be understated.  That’s why it’s good news that soon patients and prescribers will have access to cutting edge medicines called biosimilars.  Like the development of the generic medicines market, biosimilars (which will closely replicate biologic medicines) have the potential to both expand access and save lives, while also reducing cost.

In Kentucky, the state legislature is currently considering putting forth legislation that will establish a framework of regulations in which biosimilars can be introduced to patients in the state. As biosimilars come to market (as regulated by the FDA) patients fighting debilitating diseases stand to benefit greatly.

A Complex Issue

But as promising and life-changing as these drugs are, they are extremely complex, sensitive and have the ability to significantly hurt patients if not properly monitored. Legislation must ensure that when biosimilars enter Kentucky, and are potentially substituted for the more expensive brand name biologics, it is done in a way that protects patient safety and ensures transparency among physicians, pharmacists and patients.

You see, the safe and regulated introduction of biosimilars into the market has been forecasted to increase and improve access to much needed biologic medicines and reduce costs, potentially paralleling how generic drugs cost significantly less compared to brand-name drugs when they have been routinely and automatically substituted at the pharmacy.

However, in the case of biologics and their biosimilar mimics, the situation is different. Biosimilars are much more complex medications derived from living sources – not simple generics produced through chemical processes. Even the slightest difference between a biosimilar and the biologic it copies-whether in the manufacturing or even the handling process-could have a significant health impact on patients.

Ambiguity is Problematic

Because biologics and biosimilars are not molecularly the same, physicians cannot be kept in the dark about which medications their patients receive, which may be the case if Kentucky enacts legislation that does not require pharmacists to notify physicians in the event that an insurance company is requesting to substitute a biosimilar for a biologic, presumably to reduce costs.

If a physician doesn’t know exactly which product a patient is taking, he or she cannot treat adverse events or reactions, or even monitor how a patient responds to specific treatments. Further, if a patient does not know that the medication their physician intended for them to receive has been substituted, how can he or she accurately report an adverse reaction to their physician? The room for ambiguity in this process is problematic.

Therefore, while the projected affordability of biosimilars means that they hold promise for patients who need access to critical treatments, there is a need in the Kentucky state legislation to put patient safety first. Biosimilars must be properly regulated at the state level to ensure patient safety. Hence, legislation must include requirements for a pharmacist to communicate to the prescribing physician and patient if a substitution of a biologic for a biosimilar is going to occur.

Substitution Policies

As legislation is introduced in Kentucky, the Global Healthy Living Foundation will be working with patients in Kentucky who will testify about their personal stake in the legislation. Our organization believes it is imperative that the patient perspective be included in these debates as they have the most at stake when they access these life improving medications.

The core principles that the Global Healthy Living Foundation believes should guide substitution policies for biosimilars under state pharmacy laws include:

  1. Substitution should occur only when the FDA has designated a biologic product as interchangeable.
  2. The prescribing physician should be able to prevent substitution.
  3. The prescribing physician should be notified of any substitution.
  4. The patient, or the patient’s authorized representative, should, at a minimum, be notified of any substitution.
  5. The pharmacist and the physician should keep records of any substitution.

Already, patient-centric legislation has passed in North Dakota, Massachusetts, Delaware and Indiana. For more information about biosimilar substitution, visit www.GHLF.org or www.healthybiologics.org.

Stephen Marmaras is with Global Healthy Living Foundation.