Understanding Biosimilars
Summary: This article explores the imminent release of a feature within FrameworkLTC aiding pharmacies in making informed decisions on biosimilar substitutions, accompanied by an overview of biologic drugs, their classifications, and the regulatory landscape surrounding their substitution.
Table of Contents
What are biologic drugs?
What is a reference product?
What are biosimilars?
What are interchangeable biosimilars?
When can I substitute a biosimilar or interchangeable for a reference product?
What is an unbranded biologic?
The upcoming release of FrameworkLTC will introduce a new feature to help pharmacies make clinically appropriate decisions on biosimilar substitutions. As more biosimilar drugs enter the market, they create opportunities for pharmacies and patients to reduce costs and improve outcomes.
As we prepare to launch this new feature, we thought it could be helpful to provide a brief refresher on biologic drugs and address some commonly asked questions.
Biologic drugs are therapeutic agents that are derived from living organisms through biotechnology. Biologic drugs have large, complex molecular structures, and include products such as insulin (including insulin analogs such as Lantus, Humalog, and Novolog), Humira, Remicade, Enbrel, Procrit, and many others.
In March 2020, the FDA created a new reference for all licensed biologic drugs, known as the Purple Book. The Purple Book provides information on licensure, patent exclusivity, and whether the biologic drug is a reference product, biosimilar, or interchangeable product.
A biologic drug classified as a reference product is the original FDA-approved drug that biosimilar products are measured against. For example, the Purple Book classifies Neupogen as a reference product, whereas Nivestym and Zarixio are listed as biosimilars.
Biosimilar drugs are biologic products that are highly similar in structure and function to a reference product. Unlike traditional generic drugs, biosimilars are not exact molecular copies. Due to their complexity, biosimilars may have slight differences in molecular structure but have shown no clinically significant difference from the reference product in safety, efficacy, or mechanism of action.
Interchangeable biosimilars are biosimilar drugs that have met additional FDA requirements of similarity. In most states, interchangeable biosimilar drugs can be substituted for their reference products without involving the prescriber, the same as traditional generic drug substitutions.
The substitution of drugs by a pharmacist is determined by state pharmacy law. Regulations may vary from state to state on when a biosimilar or interchangeable product can be substituted for a reference product. There may also be state-specific requirements for notifying patients and prescribers when a biosimilar substitution is made.
For information on substitution laws and regulations, please check with your state pharmacy board.
An unbranded biologic is an approved biologic sold under the original biologics license application (BLA) of its brand product, but without the proprietary name on the label. The FDA does not permit manufacturers to market an unbranded biologic as a biosimilar or interchangeable version of their own reference product. Unbranded biologics may still be marketed under the sponsor’s original BLA application; however, no formal interchangeability determination is made by the FDA. Check with your state board of pharmacy for specific guidance on substituting unbranded biologics.
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