BIOSIMILAR MEDICATIONS

To encourage the development of safe and effective biosimilar medications in order to make such medications more affordable and accessible; further,

To encourage research on the safety, effectiveness, and interchangeability of biosimilar medications; further,

To support legislation and regulation to allow Food and Drug Administration (FDA) approval of biosimilar medications that are also determined by the FDA to be interchangeable and therefore supports substitution for the reference product without the intervention of the prescriber; further,

To oppose the implementation of any state laws restricting biosimilar interchangeability; further,

To oppose any state legislation that would require a pharmacist to notify a prescriber when a biosimilar deemed to be interchangeable by the FDA is dispensed; further,

To require postmarketing surveillance for all biosimilar medications to ensure their continued safety, effectiveness, purity, quality, identity, and strength; further,

To advocate for adequate reimbursement for biosimilar medications that are approved by the FDA; further,

To promote and develop education of pharmacists, providers, and patients about biosimilar medications and their appropriate use within hospitals and health systems; further,

To advocate for patient, prescriber, and pharmacist choice in selecting the most clinically appropriate and cost-effective therapy.

Rationale

A provision in the Patient Protection and Affordable Care Act created a new pathway for the FDA to approve biosimilar products. The FDA approved its first biosimilar application in March2015 for filgrastim-sndz, and others (e.g., adalimumab-adbm, adalimumab-atto, bevacizumab-awwb, etanercept-szzs, infliximab-abda, infliximab-dyyb) have followed. The FDA defines a biosimilar drug as “a biologic that is highly similar to and has no clinically meaningful differences from another biologic that is already approved by the FDA (known as the reference product).” During the FDA approval process, a new biosimilar undergoes tests to assess structural and functional components as well as limited pre-clinical and clinical studies. In order for a biosimilar to be considered interchangeable with its reference product, the FDA requires the manufacturer to additionally show that their biosimilar produces the same clinical result and switching to their biosimilar does not result in any additional risks or diminished efficacy. This typically requires additional trials, which are time consuming and costly. As of 2022, there are over 30 biosimilars approved, not all of which are commercially available, but only a select few have qualified as interchangeable due to these extensive regulatory processes.

At the state level, legislation has been proposed and enacted requiring patient and/or prescriber notification that a biosimilar medication has been interchanged. It is important to note that pharmacists cannot substitute a biosimilar medication unless the FDA has deemed that biosimilar to be interchangeable. As of 2019, 46 states and Puerto Rico have passed biosimilar substitution laws. In some states the prescriber/patient notification is similar to what is required for generic substitution, but in others it goes further. For example, Georgia’s biosimilar law requires the pharmacist to notify the prescriber within 48 hours of dispensing the medication (excluding weekends and holidays).

Despite the lack of interchangeable biosimilars, insurance companies have started requiring use of “preferred” biosimilars, leading to issues when attempting to maintain reasonable hospital formularies, patients being required to switch between biosimilar products for nonmedical reasons, and increased burden on the dispensing process when pharmacists have to contact the prescriber with every required biosimilar switch. Therefore, while health systems appear to acquire the biosimilars at lower costs, most are forced to maintain extensive formularies with all of the biosimilars in order to provide the payers preferred biosimilar for a patient. Additionally, this requirement extends into logistical burdens associated with storing, handling, and dispensing multiple similar products and increases the potential for medication errors. Due to lack of interchangeable biosimilars and payers requiring certain biosimilars to be used, a pharmacist is required to contact a prescriber each time a biosimilar needs to be changed. This interrupts workflows and prolongs the process of the patient receiving the drug.

Inadvertently dispensing the wrong product to a patient may actually lead to higher cost to the patient if their payer will not cover the dispensed product. Initially identifying which product is covered for a patient, in addition to maintaining documentation about which product is needed for future dispenses, is a time-consuming task on an already strained healthcare system.

ASHP recognizes FDA’s authority to determine biosimilar interchangeability, and in cases in which biosimilar products are deemed interchangeable, supports substitution for the reference product without the intervention of the prescriber. Further, ASHP opposes the implementation of any state laws regarding biosimilar interchangeability prior to finalization of FDA guidance and opposes any state legislation that would require a pharmacist to notify a prescriber when a biosimilar deemed to be interchangeable by the FDA is dispensed. FDA’s determination of interchangeability should be all that is needed in order to substitute the biosimilar with the reference product. Although FDA guidances are distinct from FDA regulations, they often have profound impacts on healthcare decisions and delivery, so ASHP encourages the FDA to include healthcare practitioners in their development.

ASHP recognizes that postmarketing surveillance and pharmacist evaluation as part of the formulary system before biosimilar use are required to guarantee safe use of biosimilar medications. ASHP also advocates for adequate reimbursement for biosimilars approved by the FDA. This includes opposing payer ability to dictate preferred biosimilars. ASHP encourages payers to work with health systems to align their preferred biosimilar products and for payers to cover multiple biosimilars in order to allow health systems to maintain cost-effective formularies.