Foundation Medical Board issues statement on biosimilar substitution
The National Psoriasis Foundation (NPF) Medical Board recommends that health care providers and patients have the final word when it comes to biosimilar substitutions.
Biosimilars — drugs that are similar, but not identical to biologics — are not available in the United States yet, but are expected to be soon. With the passage of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), the NPF welcomed the creation of a regulatory pathway for new, safe and effective biosimilars, adding choice and additional treatment options for the psoriasis and psoriatic arthritis community.
In contrast with generic drugs, biosimilars are not chemically identical to their branded biologics counterparts. Biologics can never be exactly replicated because of their complexity as large, intricate molecules derived from living cells using recombinant DNA technology. Because of these significant differences, the Medical Board developed the following policy to ensure patient safety.
The National Psoriasis Foundation recommends that the patient-provider relationship remain at the center of all treatment planning and supports a prohibition on biosimilar substitution unless all of the following are met:
- The biosimilar has been designated by the Food and Drug Administration as interchangeable with the prescribed biologic for the specified indicated use;
- The biosimilar has a unique nonproprietary name to eliminate confusion so providers can accurately track the drug in a patient's permanent record, and allow providers to track negative side effects;
- The biosimilar dose and the way it is given is the same as the biologic;
- The pharmacist gives 24-hour written or electronic notification to the prescriber of the intention to substitute;
- If the prescribing physician and patient do not give explicit permission for the substitution within 24 hours, the original prescription must be filled;
- The pharmacist must inform and educate the patient (or patient's authorized representative) about a biosimilar substitution at the point of sale; and
- Upon notification of a substitution, the pharmacy and the prescribing physician must retain a permanent record in the patient's medical record of the biosimilar substitution.
Learn more about the NPF Medical Board's position statement »