The U.S. Food and Drug Administration (“FDA”) is preparing to approve the first follow-on biologic drug (sometimes referred to as a “biosimilar”). (Read more about this story here.) Safe and effective biosimiliars will give patient communities a choice in treatment options. However, states should ensure they have proper substitution laws in place. Unlike small molecule generic drugs, which are easily replicable, biologics cannot be exactly replicated due to their inherent variability. Therefore, their biosimilar counterparts are not chemically identical and could pose risk to patient safety.
Many states have laws in place that allow pharmacists to replace brand-name prescription medications with cheaper generics at their discretion and without informing the patient or provider. These substitution laws will likely apply to biologics and follow-on biologics as well. Yet, both the patient and the prescriber must be informed prior to a substitution to ensure that such a change is appropriate for the patient. Therefore, states must ensure that they have proper substitution laws in place that protect patient and prescriber choice. For more information about appropriate state action, see The National Psoriasis Foundation’s recommendations on biosimiliar substitution here.
Last Updated on April 22, 2020 by Aimed Alliance
