Pharmacists Can Substitute Biosimilars

Not many people know what biosimilars are, but most people who need biological medications do.

Some rheumatoid arthritis sufferers, for instance, have gotten relief from biologics such as Humira or Enbrel. Biological medications also can be used to treat anemia, psoriasis and some types of cancer.

Biologics are chemically more complex than traditional drugs made of chemical substances; they have a larger and more complex molecular structure that can be difficult to identify and copy.

That complexity is one reason biologics cost so much. Biosimilars are new on the market, with just one biosimilar medication approved by the FDA and no FDA approvals yet of any interchangeable biosimilars (interchangeable is a higher standard of biosimilars). Biosimilars, not exactly the same as the biologics they’re based on, are expected to cost significantly less than biologics.  

The governor recently signed SB 671, by state Sen. Jerry Hill (D-San Mateo), which allows pharmacists to substitute biosimilars for biologic medications — in the style of generic substitutions. Physicians and patients need to be notified of the switch after the prescription is filled. 

“This bill is critical so pharmacists can provide lower cost medications to patients,” said bill author Hill at a Senate floor vote hearing, “and so doctors can have access to the complete medical records of their patient.”

The issue with biosimilars, said state Sen. Jeff Stone (R-Temecula) has been that they’re not the same as biologics.

“They work by the same mode of action, but they are different biological entities,” Stone said. “And as such, they may have different adverse effects.”

The law is designed to establish a standard once the FDA starts approving interchangeable biosimilars, so it technically doesn’t start until FDA approval of the interchangeable biosimilar medications.

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