Recently, Pharmacy Times reported on new research from the Journal of Managed Care & Specialty Pharmacy evaluating how the introduction of biosimilars to the U.S. healthcare market is expected to impact pharmacists in selecting and dispensing products. While these substances offer expanded options for patients and providers, their introduction to the U.S. does pose some new challenges for pharmacists.
Back Up–What are “Biosimilars”?
Unlike generics, biosimilars are products manufactured using living cell systems and are highly similar in safety and efficacy to an already FDA-approved biologic, which is known as its reference product. The biosimilar is not an exact copy, as a generic is to a chemically produced drug, and can contain clinically inactive components.
A biosimilar product may be deemed “interchangeable” with an existing biologic if it meets additional standards for interchangeability according to the FDA. Unless a product is deemed interchangeable, any substitution to the reference product must be made by a physician. For those that are classified as interchangeable, it can be left to the discretion of the pharmacist.
Reducing Cost Burden
The European Union, Canada and Australia already allow for biosimilars and are benefiting greatly. On average, they are saving an estimated 30% over biologic products. Biologics are extremely costly and, unfortunately, can be the only solution for diseases and conditions that currently have no effective treatment. It is hoped that as more biosimilars hit the market and competition comes into play, these solutions will become more affordable.
The FDA approved its first biosimilar, Zarxio (which helps prevent infections in cancer patients receiving chemotherapy), in March of this year. There is hope that this will pave the way for more approvals of biosimilars, even though no regulatory pathway has yet been set.
Guidance for Pharmacists
Once the approval pathway is open and more biosimilars are available, it will be essential for pharmacists to understand the risks associated with biosimilar substitution and state regulations around these substances. According to researchers, there are seven key questions pharmacists should ask when considering an interchangeable biologic substitution. These considerations are based on current policies regulating generic medication substitutions and include the following:
- Does state law give pharmacists the authority to autonomously substitute a biosimilar, or will the prescriber need to be contacted?
- What criteria define which products may be substituted?
- Is the biosimilar considered interchangeable with the prescribed product for all indications? If not, for what indications can it be substituted?
- Does the state require prescriber and/or patient notification or counseling?
- Does the state require record keeping of drugs dispensed and any related notifications of dispensing or substitutions?
- Is the patient being switched from one product to another? If so, are there any differences in packaging, excipients, devices, or other issues that require counseling?
- What is the scope of state legislation on substitution of interchangeable biosimilars by pharmacy practice setting?
By offering an additional option to approved medications, interchangeable biologics will give pharmacists the opportunity to customize the medications their patients receive while lessening the financial burden of their medication regimen.