In March 2015 the Food and Drug Administration (FDA) approved the first biosimilar in the US (filgrastim-sndz) and several more are expected to become available within the next few years. A biosimilar is a type of biologic product that is highly similar to another, already FDA-approved biologic, and has been judged to produce no clinically meaningful differences in safety, efficacy, purity and potency from the reference product.

As a result of the Affordable Care Act, the Public Health Service Act was amended to allow for an abbreviated licensure pathway which is authorized by the Biologic Price Competition and Innovation Act and the FDA has been finalizing guidance that has led to this initial approval. These new treatment options are expected to increase competition in the marketplace and, hopefully, lead to less expensive options to the high cost reference products. The end result could be greater access for patients in need of these new specialty medications.

New biosimilar products are already lined up in the approval pipeline and include versions of epoetin (Epogen, Procrit), pegfilgrastim (Neulasta), infliximab (Remicade), rituximab (Rituxan), adalimumab (Humira), and insulin glargine (Lantus), among others.

Biosimilars have been available in Europe for the last eight or nine years. Touting a very positive experience and an excellent safety record with these products, they now have 19 different biosimilars available for patient use. These products include versions of epoetin, filgrastim, somatropin, follitropin, infliximab, and insulin glargine. None of the European biosimilar products have had to be removed from the market for regulatory or safety concerns.

The U.S. Food and Drug Administration has adopted an approval process similar to that employed by the European Medicines Agency (EMA).

Even with rigorous testing and oversight, the introduction of biosimilars will create some important issues for the US healthcare system as they are adopted for use. Of particular interest to health systems, the following primary considerations will need to be addressed.

Formulary approval – Health system Pharmacy and Therapeutics (P&T) Committees will need to determine whether to approve biosimilar products and they will need to retain the reference product on the formulary. Assuming that there could be several biosimilar products available, they will need to select which biosimilar product(s) to make available for a specific reference product. They will also need to determine whether to consider the biosimilars therapeutically equivalent for all or only selected indications.

Pharmacovigilance – A robust pharmacovigilance program will be needed in order to detect any safety problems with a particular biologic product. A key factor is the ability to specifically determine which product(s) have been used by a patient. This means that clear identifiers must be captured in our dispensing systems to allow tracking of a specific product to a patient. While this is relatively straightforward in outpatient dispensing systems that capture the 11-digit NDC number for products dispensed, there will need to be adjustments in most health system information systems in order to assure that the specific product information is captured. Complicating this process is the fact that the FDA has yet to finalize a naming convention for biosimilar products.

Transitions of Care – Health system P&T Committees will need to make policy decisions on how to manage biosimilars as patients transition between the outpatient environment and hospitals. With small molecule generic products, there is not much concern around the substitution of products. However, with biologics there is a desire to minimize switching between different products due to the theoretical risk of inducing immunogenic reactions or creating neutralizing antibodies.

Policies will need to be developed to address whether a patient who is maintained on an existing biological product will be allowed to stay on that product or whether s/he will be switched to the health system’s formulary agent when that patient is admitted to the hospital. Similar considerations will need to be made when patients are initiated on a product in the hospital and are then discharged with home administration covered by an outpatient prescription drug plan.

Interchangeability – The FDA will be establishing criteria for a biosimilar to achieve a higher level of approval as an “interchangeable biosimilar.” This designation would be very similar to a generic small molecule drug in that it would be judged safe to interchange a patient between the reference product and the biosimilar without any concern for safety or efficacy. Since the FDA has not yet finalized guidance on the requirements for this designation, the first biosimilars approved will not have the “interchangeable” designation.

Many states have passed legislation dictating the conditions under which pharmacists may substitute a biosimilar product for a reference product. It is important for healthcare professionals to be aware of both the FDA designation as well as applicable state laws regarding biosimilar substitution. As a reference for biologics, the FDA has created the “Purple Book” which is similar to the “Orange Book” for small molecule generic products.


Biosimilars represent a major opportunity to help control rising healthcare costs and to improve patient access to what are currently very expensive biologic therapies. Federal and state regulatory actions, pricing and reimbursement policies, and clinical factors will all affect decisions regarding the introduction of biosimilars in health systems. Pharmacists and other healthcare providers will need to be aware of the issues in order to make responsible policy decisions on the use of these new products.

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