Will Biosimilars be the Future of Specialty Pharmacy?

Biologics: What Are They and Why Are They Different?
When I think back to pharmacy school, one of the first courses I took was organic chemistry, in which we learned about the structure, properties, and composition of molecules and how various reactions created new, more extensive compounds. Even though this sounds complex, this does not even compare to the complexity of a biological agent.
 
Although there are several different types of biological products, which the FDA notes includes proteins, monoclonal antibodies, and vaccines with little in common. For example, biologic drugs are large molecules typically manufactured from living cells and, therefore, are extremely difficult to produce or reproduce. In fact, there can be variations of acceptable range within the same manufacturing process because biologics are processed using living cell-based technology and the make of these agents is not easily identifiable.
 
For this reason, they are also highly sensitive to storage and handling processes and typically have a shorter shelf life than your average oral medications. So, why research, develop, and ultimately manufacturer such complex, sometimes costly medications you might ask? Because they are able to effectively treat a variety of medical conditions that previously had limited to no other treatments available, thereby changing the lives of patients with conditions such as rheumatoid arthritis, cancer, and anemia, just to name a few.
 
Generic Biologics
Although biosimilars and generic medications are both versions of brand name drugs, because of the complexity of biologics, existing regulations in place, such as the Hatch-Waxman Act (which encourages manufacturers to market generic drugs to create competition and lower health care costs) do not apply to biologics. However, approximately 8 years ago, the Biological Price Competition and Innovation (BPCI) Act was passed to expedite the approval of biological products that have shown biosimilarlity or interchangeability with a biologic drug already approved by the FDA. Biosimilarity refers to a biologic that has demonstrated similar efficacy and safety with no clinically-meaningful differences from the FDA-approved reference product.
 
The FDA allows biosimilarity to be proven through an analysis of the reference product’s purity, chemical identity, and bioactivity. Interchangeability, however, refers to a biologic being that can be substituted for the reference product by a pharmacist requiring the approval of the health care provider who prescribed the reference drug. To attain interchangeability, additional information must be provided that ultimately demonstrates the biosimilar product produces the same clinical result as the reference product without compromising safety or efficacy by alternating or switching between the products. To date, no biosimilars have received FDA approval for interchangeability.
Since the passage of the BPCI Act, approximately 12 biosimilars have been approved by the FDA, yet only 3 are currently available at the time of this writing. These biomsiliars include Zarxio, indicated for the treatment of low neutrophils, and Inflectra and Renflexis, both indicated for the treatment of rheumatoid arthritis.
 
Limited Utilization to Date
Despite being available in the market, use of these products to date have not taken off. There are a number of reasons why we have not seen high utilization of biosimilars in the United States like we have seen in other areas of the world, such as the European Union. Some of these factors include the lack of regulatory direction regarding interchangeability, which leads to the inability to automatically substitute a lower cost alternative when dispensing a medication, as well as legal actions between manufacturers regarding patent litigations.
 
Additionally, similar to what was observed initially with generic medications, there is a lack of awareness and confidence from both patients and prescribers regarding biosimilars. Finally, the cost difference between the branded and biosimilar product may not be enough to incentivize a change in prescribing patterns and patient demand. Some of these reasons are discussed in more detail below.
 


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