Biosimilars vs Biologics: What Pharmacy Technicians Should Know
Understand the difference between biologics and biosimilars, how they are approved, and why they cannot be substituted like traditional generics. PTCE exam essentials.
What Are Biologics?
Biologics are complex medications derived from living organisms such as bacteria, yeast, or animal cells. Unlike small-molecule drugs made through chemical synthesis, biologics are large, intricate proteins that are sensitive to manufacturing conditions. Examples include adalimumab (Humira), insulin glargine (Lantus), trastuzumab (Herceptin), and filgrastim (Neupogen).
What Are Biosimilars?
A biosimilar is a biologic product that is highly similar to an already approved reference biologic with no clinically meaningful differences in safety, purity, or potency. However, because biologics are made from living systems, a biosimilar is never an exact copy of the reference product. This is why the term "biosimilar" is used instead of "generic."
The Approval Pathway
Biosimilars are approved under the Biologics Price Competition and Innovation Act (BPCIA) via an abbreviated pathway (351(k) application). Manufacturers must demonstrate biosimilarity through analytical studies, animal studies, and at least one clinical study. The FDA may grant an interchangeable designation if additional switching studies show the biosimilar can be substituted for the reference product without prescriber intervention.
Interchangeability vs Biosimilarity
This distinction matters in pharmacy practice:
- Biosimilar - Approved as highly similar but may require prescriber approval for substitution, depending on state law.
- Interchangeable biosimilar - Can be substituted at the pharmacy level without prescriber approval, similar to generic substitution. State laws vary on implementation.
Why This Matters for Pharmacy Technicians
Biosimilars are increasingly common in pharmacy inventory. Technicians must understand that biosimilars have different NDC numbers, may have different brand names, and follow different substitution rules than traditional generics. Insurance formularies may prefer a biosimilar over the reference product, requiring technicians to process prior authorizations or communicate changes to patients.
This topic bridges the medications and federal requirements domains of the PTCE, making it valuable study material.
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