State Legislation Needed For Substitution of Interchangeable Biologics

Jim's Corner

A great deal of the media coverage relating to California’s Senate Bill 598  neglects to mention a key issue in the biosimilars debate.

This bill – or legislation similar to it – is essential to allow for the eventual substitution of interchangeable biologic therapies in the state of California.

State laws governing prescription drug substitution were written before the advent of biosimilars and do not take the complexity of biologics into account. California, along with most other states,  must update current laws to ensure patients have access to lower cost biologics. Given the complex nature of these products, BIO advocates that the physician be notified when a substitution occurs.

Very shortly, California’s Senate will once again vote on SB 598. This bill ensures that California’s doctors who are treating patients with dreaded diseases, know exactly what drug is being dispensed.

With all biologics, minor differences in how they are made, packaged or shipped can alter the end product. Two biologics are rarely, if ever, exactly the same. Simply put, there is no such thing as a “generic biologic.”

Patient and physician notification of drug substitutions and other patient protection measures are the most effective means of ensuring that all parties involved know the precise course of treatment taken by any given patient.

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