The introduction of biological therapies, or “biologics,” for the treatment of psoriasis and psoriatic arthritis has been among the most significant advancements in recent decades. For most biologics approved for the treatment of psoriasis and/or psoriatic arthritis, long-term efficacy and safety are well established. 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 biosimilars, which adds accessibility and additional treatment options for the psoriasis and psoriatic arthritis community. The Food and Drug Administration (FDA) has approved several biosimilars with indications for the treatment of psoriasis and psoriatic arthritis. Biosimilars hold the promise of substantial cost savings in health care while maintaining efficacy and safety of the reference product. The NPF Medical Board strongly believes that individuals living with psoriasis and psoriatic arthritis who use biosimilars should benefit from out-of-pocket cost savings and receive cost-sharing protections. The NPF Medical Board posits the following regarding the use of biosimilars in patients with psoriasis and psoriatic arthritis.
Position Statement on the Use of Biosimilars for Psoriasis and Psoriatic Arthritis
1. We consider biosimilars to be similar to the reference product in the treatment of psoriasis and psoriatic arthritis.
All biologic medications, including reference products (also known as the originator or innovator products), come from living systems (e.g. bacteria and yeast). Thus, it is nearly impossible to consistently create an identical copy of a biologic. Even with the same reference product produced by the same manufacturing plant using the same cell line, dissimilarities can exist from batch to batch. To be approved by the FDA, biosimilars must have (1) identical therapeutic amino acid sequences relative to the reference product and (2) demonstrate biosimilarity through pharmacodynamic, pharmacokinetic, and immunogenicity studies.
Most biosimilars obtain FDA approval in psoriasis and psoriatic arthritis via extrapolation. Extrapolation is an established scientific and regulatory principle where biosimilarity to the reference product has been shown by a comprehensive comparability program, including safety, efficacy, and immunogenicity for another indication (e.g. rheumatoid arthritis). Thus, most biosimilars for psoriasis and psoriatic arthritis are approved without the need to repeat clinical trials. Such designation is not automatic and is based on assessment of scientific justification. Of note, some biosimilars may differ from the reference product in certain aspects, including delivery device, product concentration, and citrate content. However, for all practical purposes, we deem biosimilars approved by the FDA to be similar in efficacy and safety to the reference product in treating psoriasis and psoriatic arthritis.
2. We recognize the interchangeability of biosimilars with the additional regulatory designation of “interchangeability” and concur with substitution of reference products for biosimilars where appropriate.
In the U.S., some biosimilars have an additional regulatory designation termed “interchangeability,” which means that the biosimilar can be substituted for its reference product at the pharmacy without additional approval from the prescribing physician. The interchangeable designation may be granted for a biosimilar when additional “switching” clinical studies demonstrate no additional risk or reduced efficacy, if a patient switches back and forth between a reference product and a biosimilar, as compared to continuing on the reference product. Although interchangeability is granted at the federal level by the FDA, state laws govern (1) local dispensing and substitution of drugs at the pharmacy level and (2) whether to notify patients or providers about the substitution. Potential cost-savings may occur when a pharmacy substitutes a reference product with an interchangeable biosimilar. We recognize and concur with the substitution of reference products for interchangeable biosimilars at the pharmacy.
3. A loss in efficacy or tolerability to a reference product or its biosimilar product may warrant switching to a different medication, rather than to another biosimilar of the reference product.
If a patient loses efficacy or tolerability to a reference product or its biosimilar product, we urge clinicians to consider a different medication. Due to the biosimilarity between the reference product and all of its biosimilars, the etiology for a patient’s loss of efficacy or tolerability to a reference product or to one of its biosimilars is likely to be extrapolated to another biosimilar of the same reference product.
In closing, the NPF urges that all therapeutic decisions are made through a shared decision-making process between the clinician and the patient, in which the patient’s wellbeing remains at the center of this process.
From the Medical Board of the National Psoriasis Foundation:
April Armstrong, Kristina Callis-Duffin, Steven Feldman, Brad Glick, Robert Kalb, Soumya Reddy, Sergio Schwartzman, Paul Yamauchi, Cassandra Calabrese, Kelly Cordoro, Seemal Desai, Dafna Gladman, George Han, Jason E. Hawkes, Sylvia Hsu, Leon Kircik, John Koo, Gerald G. Kreuger, Mark Lebwohl, Craig Leonardi, G. Michael Lewitt, Wilson Liao, Clive Liu, Joseph Markenson, Joseph F. Merola, Ana-Maria Orbai, Ronald Prussick, Veronica Richardson, Jennifer Soung, Abby S. Van Voorhees, Elizabeth Wallace, Jeffrey Weinberg, Lara Wine Lee, Jason Harris, Samantha Koons, Leah Howard