To many cooks...
State lawmakers are not biomedical experts. They didn't even stay at a Holiday Inn Express last night. But they're not afraid to wade into a highly complex pharmaceutical issue that appropriately is within the realm of the U.S. Food and Drug Administration.
At issue are "biosimilars," generic versions of highly complex drugs that are derived from a living organism through molecular cloning or other highly complex techniques.
Making generic copies of those drugs is far more complicated than making generic versions of chemically formulated drugs.
For chemicals, if you have the formula you can make an exact copy. For biosimilars, it's not so simple. The molecules are far larger and far more complex and they are susceptible to a far wider array of variables in the replication process.
Congress endowed the FDA with the authority to license biosimilars, and the FDA has established a rigorous process to ensure that biosimilars are close enough to the patented biologically derived drug to be safe and to act as intended. Just a few biosimilars have been approved.
State House and Senate bills needlessly would erect barriers between patients and their doctors, and between patients and safe biosimilars.
The bills would require patients to consent in writing to a biosimilar substitution for a prescribed biological drug; the pharmacist would have to notify the physician within 72 hours and the prescribing doctor would have to maintain a written record of the transaction for five years.
Such notification laws have become something of a trend in state legislatures. Small wonder. Lawmakers aren't doctors but they are Ph.D.s at raising campaign money. Two large pharmaceutical companies heavily invested in patented biologics, Amgen and Genentech, have contributed heavily to state lawmakers across the country in the effort to hinder biosimilars.
State lawmakers should leave biosimilar regulation with the FDA, where it belongs.