Below is the official statement from the National Psoriasis Foundation Medical Board on biosimilar substituion.
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Considered by the National Psoriasis Foundation Medical Board on February 28, 2013; Revised and Approved on July 31, 2013
The introduction of biologic products for the treatment of psoriasis and psoriatic arthritis has been the most significant advancement in care for the psoriasis and psoriatic arthritis community in recent decades. Biologics have provided some patients with an effective therapy—many for the first time in their lives. Biologics have also opened up a new world of combination therapies being used alongside systemic treatments, phototherapy and/or topical treatments. With the passage of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), the National Psoriasis Foundation (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. While the community welcomes new and affordable treatments, patients with psoriasis and psoriatic arthritis are keenly aware of the risks associated with biologics, including suppression of the immune system and the lack of long-term safety data for new treatments.
In contrast to the case with generic drugs, which are chemically identical to their branded counterparts, biosimilars are not chemically identical to their branded biologics 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. Due to these significant differences, the NPF has 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 minimal thresholds 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, 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;
- the biosimilar product follows the same route of administration and dosage form as the reference product;
- the pharmacist notifies the prescriber in writing or electronic communication of the intention to substitute at least 24 hours prior to the substitution;
- if explicit permission from prescribing physician and patient is not obtained within 24 hours, then the original prescription must be filled;
- the patient (or patient's authorized representative) must be informed and educated about a biosimilar substitution at the point of sale; and
- 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.
The above position statement is to serve as protection for the physicians, pharmacists, insurers and above all, patients from any harm that may result from biosimilar substitution.