Back in July, the FDA approved the first interchangeable biosimilar in the US and it’s for Viatris’ Semglee (insulin glargine-yfgn). This is a huge deal for patients with type 1 or type 2 diabetes due to the treatment being high-quality, but lower cost than insulin. While this new development is extremely exciting, where do pharmacists come into play with this treatment? Retail pharmacists may now be the ones to decide if a prescription is filled with the reference product or with the biosimilar being that it will primarily be dispensed at their pharmacies.
With that being said, it is important for you to be fully educated on biosimilars so you can make the right decision when filling these prescriptions. Take a look at an overview of biosimilars and some things you should know about them:
A biosimilar is an FDA-approved biologic product that is extremely similar to an existing FDA-approved biologic product, also known as the reference product. Most importantly, there are no clinically meaningful differences between the products in terms of safety, purity, and effectiveness but is available at a lower cost. However, due to biologics being large and manufactured from living cells, they cannot be exact replicas. Despite there already being 30 biosimilars that have been approved by the FDA, insulin will be the first that will be primarily distributed by pharmacies and not by providers.
When a biosimilar is deemed interchangeable, this means that it will have the same clinical outcome as the reference product. This is proven by conducting studies in which patients’ prescriptions are alternated between the reference product and the biosimilar multiple times, otherwise referred to as switching studies. In the case of insulin, the FDA decided that these studies were not necessary which is why it got the green light so quickly. In regard to pharmacists, interchangeability can allow pharmacists to substitute the biosimilar without consulting a physician. Although, this of course will depend on state laws.
- State Regulations
As you know, pharmacy laws and regulations are determined by each state and currently every state and the District of Columbia have laws pertaining to interchangeability. The laws include requirements related to provider notification/permission, patient communication, and documentation practices. Some states even have laws that allow the change, only if the biosimilar is at a lower cost for the patient. To look at the laws on interchangeability in your state, look here.
As pharmacists, your job is to help your patients to the best of your ability. For many, a common issue with prescription medications is the cost factor. The US has the highest drug cost in the world and biosimilars are one way to try and combat this. Due to gaps between gross and net prices caused by rebates and such, pharmacists need to be properly educated on the various managed care decisions. These include but are not limited to PBM/payer formularies and policies that ultimately dictate reimbursement and patient costs. Insulin is one of the highest rebated products leaving the gap between gross and net costs at more than 50% in some cases.
- Patient Education
According to research, awareness and understanding of the biosimilars are considerably low among patients and even some health care providers. With pharmacists being one of the most trusted and most used health care providers, it is important that you know the facts so you can properly educate your patients. The high demand for affordable diabetes treatments across the US, puts pharmacists in a unique position to advance the quality of patient care.
According to Peter Stein, MD, director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research, “The FDA’s high standards for approval mean health care professionals and patients can be confident in the safety and effectiveness of an interchangeable biosimilar product, just as they would for the reference product.” For more information and tools on biosimilars, visit the FDA website.