Biosimilar Dilemma

The passage of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) allowed for the creation of a regulatory pathway for new, safe, and effective biosimilar agents. Although the medical community always needs new and affordable treatments, patients and physicians are aware of and concerned about the risks associated with biologics and the lack of long-term safety data for new treatments.

In contrast to generic drugs, which are chemically identical to their branded counterparts, biosimilar agents are not chemically identical to their branded biologic counterparts because as large complex molecules derived from living cells using recombinant DNA technology, biologics can never be exactly replicated due to their inherent variability.

Because of these substantial differences, the National Psoriasis Foundation released a policy in July 2013 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 minimal thresholds are met:

1. the biosimilar has been designated by the Food and Drug Administration as interchangeable with the prescribed biologic for the specified indicated use;
2. the biosimilar has a unique nonproprietary name to eliminate confusion, to allow providers to accurately track the therapeutic agent in a patient's permanent record, and to allow for the collection of adverse event information;
3. the biosimilar product follows the same route of administration and dosage form as the reference product;
4. the pharmacist notifies the prescriber in writing or electronic communication of the intention to substitute at least 24 hours prior to the substitution;
5. if explicit permission from prescribing physician and patient is not obtained within 24 hours, then the original prescription must be filled;
6. the patient (or patient's authorized representative) must be informed and educated about a biosimilar substitution at the point of sale; and
7. upon notification of a substitution, the pharmacy and the prescribing physician are to retain a permanent record in the patient's medical record of the biosimilar substitution.

What’s the issue?

The tension between lowering costs and using trusted therapeutic options will be at the center of the debate over biosimilar agents. The National Psoriasis Foundation policy protects physicians and patients and helps maintain their autonomy. As these drugs are developed and studied, we will have more information to inform our decisions. How will you and your patients respond to the availability of biosimilar agents?

We want to know your views. Tell us what you think.